Pharmacy Benefit Resources

Completely exclude medications even in a 3-tier plan?

2014-01-09T13:27:00.003-05:00

If those medications use co-payment coupons to circumvent your benefit design then I suggest the answer is yes.

From RxObserver:

"PBM Express Scripts was recently in the news for announcing that its 2014 formulary would exclude from all coverage 48 prescription products. Some 93% of the newly excluded products use copay coupons to get around plan design features intended to encourage plan beneficiaries to use less expensive, but equally effective prescription drugs. "

Key drug approval: Solvadi for Hepatitis C

2013-12-12T09:46:00.000-05:00

Expect lots of hepatitis C patients to receive this medication since it can be used without an interferon. Patients dislike taking interferons since it makes them feel like they have the flu every time the receive it.
It costs $84,000 for the 12-week treatment.

Press release

Express Scripts claims they will aggressively pit the multiple hepatitis C treatments against each other in an effort to lower costs without lowering quality. Here's the Drug Channels link. I'll be interested to see if they can pull that off.

Office administration of specialty infusion drugs may be less expensive than home infusion.

2013-12-12T09:39:00.001-05:00

Here's a link to a very informative article from Drug Channels. This chart highlights how relying on your PBM for all specialty drugs might not be the best idea.

Another from Enabling Health Decisions. The question is whether care can be improved or cost reduced for these 3.6% of members. Your care management vendor should be providing you with those answers.

Outpatient Drug Approvals for October 2013

2013-11-12T14:28:00.000-05:00

Zohydro ER (hydrocodone) Extended-Release Capsules

Treatment for: Pain

Zohydro ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.

Comments: Like Oxycontin, this medication can provide needed relief to true severe pain patients but will be abused by many others.
-more-

Zorvolex (diclofenac) Capsules

Treatment for: Pain

Zorvolex (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain.

Comments: A low value medication. Consider requiring a prior authorization or high patient pay.

Otrexup (methotrexate) Subcutaneous Injection

Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis

Otrexup (methotrexate) is a folate analog metabolic inhibitor self-administered once weekly for use in the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis.

Comments: I don't see a particular value over inexpensive, oral methotrexate.

Duavee (bazedoxifene and conjugated estrogens) Tablets

Treatment for: Postmenopausal Symptoms, Prevention of Osteoporosis

Duavee (bazedoxifene and conjugated estrogens) is an estrogen agonist/antagonist and conjugated estrogens combination indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, and prevention of postmenopausal osteoporosis in women with an intact uterus.

Comments: Limited evidence this provides better safety than other estrogen products for menopausal symptoms. Patients should limit use to the shortest duration possible.

The following medications will be very expensive though likely used in relatively few patients.

Opsumit (macitentan) Tablets

Treatment for: Pulmonary Hypertension

Opsumit (macitentan) is a dual endothelin receptor antagonist for the treatment of patients with pulmonary arterial hypertension.

Adempas (riociguat) Tablets

Treatment for: Pulmonary Hypertension

Adempas (riociguat) is an oral soluble guanylate cyclase (sGC) stimulator for the treatment of pulmonary hypertension.

Novoeight (turoctocog alfa) for Intravenous Injection

Treatment for: Hemophilia A

Novoeight (turoctocog alfa) is an antihemophilic factor (recombinant) indicated for use in adults and children with hemophilia A.

Independent Pharmacy Profit Margins Not Driving Rising Medication Costs

2013-11-08T11:12:00.001-05:00

Per Drug Channels: "Given the slight increase in gross margin, gross profit dollars per prescription grew slightly, from $12.40 per prescription in 2011 to $12.61 per prescription in 2012."

While you can save some money using a preferred pharmacy network a focus on improving prescribing habits presents a far greater opportunity for savings and improved quality.

Update: 11/14/13
Wal-Mart recently aired commercials promoting their preferred pharmacy network option. If you're interested in a preferred network please note that CMS found that of 13 plans reviewed there were eight (8) that were less expensive and five (5) that were more expensive than the traditional plan. It's not enough to just choose to use a preferred network. You need a solid analysis of savings, guarantees of those savings and audits to confirm.

National Health Expenditures

2013-10-23T12:52:00.000-04:00

Abstract from Health Affairs article

Unfortunatlely, the article isn't free.

"Health spending growth through 2013 is expected to remain slow because of the sluggish economic recovery, continued increases in cost-sharing requirements for the privately insured, and slow growth for public programs. These factors lead to projected growth rates of near 4 percent through 2013. However, improving economic conditions, combined with the coverage expansions in the Affordable Care Act and the aging of the population, drive faster projected growth in health spending in 2014 and beyond. Expected growth for 2014 is 6.1 percent, with an average projected growth of 6.2 percent per year thereafter. Over the 2012–22 period, national health spending is projected to grow at an average annual rate of 5.8 percent. By 2022 health spending financed by federal, state, and local governments is projected to account for 49 percent of national health spending and to reach a total of $2.4 trillion."

Note the acceleration in prescription sales starting in 2014. Much of this will come from increasing specialty drug sales. It's a good time to start talking to your PBM about how to manage this growth.

Co-pay Discount Cards = Poor Value

2013-10-23T12:38:00.001-04:00

At least in most cases. Express Scripts recently dropped 48 brand-name drugs from their preferred formulary. The drug companies offer co-pay cards for 93% of them. You should consider asking your PBM for their approach to these same drugs.

Here's a link to a list of co-pay cards and coupons. If you see a drug on this list it likely means it is unnecessarily expensive.

Outpatient Drug Approvals for September 2013

2013-10-23T12:31:00.001-04:00

Brintellix (vortioxetine) Tablets

Treatment for: Depression

Brintellix (vortioxetine) is a multimodal antidepressant for the treatment of major depressive disorder (MDD).

Comments:

Similar to Cymbalta and offers no new benefits to patients with depression.

Recommended Value Rating: D (high-cost per success)

Recent Outpatient Drug Approvals through August 2013

2013-10-23T12:21:00.000-04:00

The greatest impact for your trend will likely be the new cancer agents that continue to allow treatment to move from inpatient to outpatient settings.[1]

Addiction

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Company: Orexo AB
Date of Approval: July 3, 2013
Treatment for: Opiate Dependence

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

· FDA Approves Zubsolv for the Maintenance Treatment of Opioid Dependence - July 8, 2013

Cancer

Gilotrif (afatinib) Tablets

Company: Boehringer Ingelheim Pharmaceuticals Inc.
Date of Approval: July 12, 2013
Treatment for: Non-Small Cell Lung Cancer

Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

· FDA Approves Gilotrif for Late Stage Non-Small Cell Lung Cancer - July 12, 2013

Mekinist (trametinib) Tablets

Company: GlaxoSmithKline
Date of Approval: May 29, 2013
Treatment for: Melanoma - Metastatic

Mekinist (trametinib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

· FDA Approves Mekinist (trametinib) for Advanced Melanoma - May 29, 2013

Tafinlar (dabrafenib) Capsules

Company: GlaxoSmithKline
Date of Approval: May 29, 2013
Treatment for: Melanoma - Metastatic

Tafinlar (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Cardiovascular

Epaned (enalapril) Powder for Oral Solution

Company: Silvergate Pharmaceuticals Inc.
Date of Approval: August 13, 2013
Treatment for: Hypertension

Epaned (enalapril) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month.

· FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults - August 14, 2013

Depression

Fetzima (levomilnacipran) Extended-Release Capsules

Company: Forest Laboratories, Inc. and Pierre Fabre Laboratories
Date of Approval: July 25, 2013
Treatment for: Depression

Fetzima (levomilnacipran) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

· Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of Fetzima for the Treatment of Major Depressive Disorder in Adults - July 26, 2013

Khedezla (desvenlafaxine) Extended-Release Tablets

Company: Osmotica Pharmaceutical Corp.
Date of Approval: July 10, 2013
Treatment for: Depression

Khedezla (desvenlafaxine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

FDA Approves Khedezla for Major Depressive Disorder - July 11, 2013

Endocrine

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) Tablets

Company: Warner Chilcott plc
Date of Approval: July 24, 2013
Treatment for: Contraception

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) is an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy.

· Warner Chilcott Announces FDA Approval of Lo Minastrin Fe - July 25, 2013

Brisdelle (paroxetine mesylate) Capsules - formerly LDMP

Company: Noven Pharmaceuticals, Inc.
Date of Approval: June 28, 2013
Treatment for: Hot Flashes Associated with Menopause

Brisdelle (paroxetine mesylate) is a low-dose selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

· FDA Approves Brisdelle - First Non-Hormonal Treatment for Hot Flashes Associated with Menopause - June 28, 2013

Epilepsy

Trokendi XR (topiramate)

Company: Supernus Pharmaceuticals, Inc.
Date of Approval: August 16, 2013
Treatment for: Epilepsy

Trokendi XR (topiramate) is an antiepileptic drug indicated for the treatment of epilepsy.

· Supernus Announces Final FDA Approval and Upcoming Launch of Trokendi XR - August 19, 2013

Hemophilia

Rixubis (coagulation factor IX (recombinant)) Injection

Company: Baxter International Inc.
Date of Approval: June 26, 2013
Treatment for: Hemophilia B

Rixubis (coagulation factor IX, recombinant) is an antihemophilic factor indicated for the control and prevention of bleeding episodes in adults with hemophilia B.

· FDA Approves Rixubis - First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes - June 27, 2013

HIV Infection

Tivicay (dolutegravir) Tablets

Company: ViiV Healthcare
Date of Approval: August 12, 2013
Treatment for: HIV Infection

Tivicay (dolutegravir) is an integrase inhibitor indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1.

· FDA Approves Tivicay (dolutegravir) to Treat HIV Infection - August 12, 2013

Organ Transplant

Astagraf XL (tacrolimus) Extended-Release Capsules

Company: Astellas Pharma US, Inc.
Date of Approval: July 19, 2013
Treatment for: Organ Transplant -- Rejection Prophylaxis

Astagraf XL (tacrolimus) is a calcineurin-inhibitor immunosuppressant for the prophylaxis of organ rejection in patients receiving a kidney transplant.

· Astellas Announces FDA Approval of Astagraf XL (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection - July 22, 2013

Respiratory

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder

Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Date of Approval: May 10, 2013
Treatment for: Chronic Obstructive Pulmonary Disease

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD).

· FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD) - May 10, 2013

Source: Drugs.com

[1] http://www.drugs.com/newdrugs.html

Can devices improve medication adherence?

2013-01-09T12:43:00.001-05:00

Link to the article in the Wall Street Journal.

My reaction:

Blister packing works well and is relatively easy for brand name manufacturers to incorporate. I could see this as a possible competitive advantage. Generic manufacturers have little incentive to add this cost.

If you want something to remind you then an alarm on the cellphone seems to have the most utility. You could also set up a service that uses text messaging to remind and confirm. Physical devices don't make sense to me.

Can generic discount programs save you money?

2012-12-08T12:24:00.002-05:00

This publication suggests that generic discount programs (e.g., $4 generics) results in ~10% fewer levothyroxine prescriptions being submitted to the PBM for adjudication. Sounds good until you balance the savings against the loss of data for clinical programs. Saving 10% on inexpensive medications will have a very limited impact on your medication costs and trends.

Not having these claims will weaken your point-of-service programs (e.g., interaction) checking and other clinical programs such as care gap alert systems (e.g., poor adherence) and care management services. It doesn't take many patients with a potentially avoidable hospital admission to wipe out the savings.

Consider making these same drugs a $4 co-payment or less with your benefit. Then inform your beneficiaries that they have a comparable program available through their benefit program and can be used at any pharmacy in your network.

I estimated the additional waste created by 90-day supplies at 4-5%

2012-12-08T12:04:00.000-05:00

A recent publication from Walgreens employees suggests a lower amount of waste. The primary difference likely results from their calculating waste only from switches to a different strength or medication. My analyses also included patients that discontinued therapy for a condition. This commonly occurs approximately 6 months after starting a medication. Conceptually, a patient would "waste" an average of 15 days of medication following discontinuation of a 30-day supply. Patients with a 90-day supply would waste an average of 45 days of medication.

I prefer 30-day supplies when a program includes an alert identification and notification system that relies on claims data. This allows the system to identify potential gaps in care sooner than with 90-day fill intervals.

The op-ed piece in the same journal also explains some caveats related to this study.

Coupons in Part D Programs?

2012-12-08T11:19:00.000-05:00

Here's the link to the Drug Channels post on coupons in Part D programs. Does the CBO now support co-pay cards for Medicare Part D? They're current banned by they way. Here's my favorite bit of information:

"For a specialty drug, the average monthly cost per prescription is usually $2,000 to $3,000, so cost sharing can create an enormous financial burden for seniors. To help patients afford these out-of-pocket expenses, pharmaceutical manufacturers offer co-pay offset programs that cover the patient’s portion. Per A New Reality Check on Co- Pay Offset Programs, nearly 70% of biological drugs have co-pay programs, compared with only 44% of traditional brand-name drugs."

I noted my general concerns about coupon programs in the prior post. Coupons usually exist only for unnecessarily expensive medications where the manufacturer wants to counter the benefit design and formulary management of the payers.

Consider reference pricing to counter copay discount programs

2012-11-14T13:12:00.000-05:00

In case you don't know the specifics about the problems with co-payment discount programs here's an example of how manufacturers can bypass the limits of your non-preferred formulary tier.

Coupons for Patients, but Higher Bills for Insurers

Solodyn (once-daily minocycline) cost per month: $700
Non-preferred co-payment: $50
Patient pay after manufacturer discount: $20
Plan pays: $650

Twice a day minocycline costs less than $40. The patient pays the $10 generic co-payment and the plan pays $30.

Consider using reference pricing. How does this work? You could set the reference price for all forms of minocycline at $40. Patients that receive generic minocycline only pay their $10 co-payment and the plan pays the $30.

If the patient gets Solodyn they would pay the $10 generic co-payment PLUS the difference in cost between the drugs. That would create a co-payment of $10 plus ($700-$40) which equals $670. The plan pays the $30 regardless of whether they get generic minocycline or Solodyn. The manufacturer would be unlikely to pick up the difference.

Manufacturers typically offer these programs only for high-cost brand-name medications that have equally or more effective competing medications at much lower prices.

Click this link for an idea of the scope of this problem.

Update: 11/20/12
New AJMC article: A Systematic Review of Reference Pricing: Implications for US Prescription Drug Spending

Key extract:
"Alternatively, reference pricing could be embedded in tiered formularies. For example, in contrast to placing all generic products in the lowest tier of incentive formularies as is currently practiced, 1 generic product in each therapeutic class could be set as the referent drug and the prices of other generics set according to this. For brand name products, reference pricing could be used to set the same price for multiple products in the same therapeutic class. Currently, preferred prices are set through negotiations between pharmacy benefit management and manufacturers and only 1 brand name product in each class has preferred status. By setting a fixed level of reimbursement, more than 1 product may effectively obtain preferred status, making the prices more competitive and increasing the transparency of the price negotiation and setting process. On the other hand, this process may eliminate incentives for manufacturers to provide pharmacy benefit managers with discounts in exchange for preferred formulary status, and thus the application of reference pricing to brand-name products may have unclear implications for pricing."

Want to compare what you're paying to "actual" acquisition cost?

2012-11-14T12:32:00.000-05:00

Here's the link to the site for Alabama's actual acquisition cost (AAC). The AAC will vary from pharmacy to pharmacy due to a variety of factors such as volume discounts, special deals, source (e.g., direct, wholesaler) and pharmacy type. Yes, mail-service pharmacies get better deals on generic medications. Purchasers at mail-service pharmacies have told me their discounts typically exceed AWP - 95%. Keep in mind that AWP is no better than a "sticker price."

Our most recent analysis showed a client paying an average of AAC plus 18.1%. This equaled a profit margin of $15.80 per prescription.

Drug Channels reports $12.40 profit per Rx for independent pharmacies

2012-11-14T12:22:00.001-05:00

For details please go to

Pharmacy Ownership: Getting Less Profitable

Keep in mind the facts come from an independent pharmacy association.

15 of 44 Health Economists Oppose Current FDA Approval System

2010-05-07T11:21:00.000-04:00

The article asked a wonderful set of questions. I decided I'd stick my neck out and give my initial thoughts (italicized) on these questions and even throw in a few comments designed to "stimulate" the conversation. So don't believe everything I say. (Like I needed to tell you that.)

The policy that requires pre-market approval of new pharmaceuticals and medical devices may prevent harm, and it also may suppress would-have-been benefits (by suppressing drug development, causing delays, or increasing costs). This may be particularly true for less common conditions.
Consider now only the second policy effect, suppression of would-have-been benefits. Which of the following statements best describes your view of the public discourse about this effect? The Orphan Drug Act addressed rare, but not common, conditions. Many people may turn to alternative, relatively untested, therapies because they don't have good FDA-approved options.
Which best describes your attitude toward the U.S. government policy that requires pre-market approval of new pharmaceuticals and devices? Greater access to information and shared expertise will continue to shape my opinion.
Do you think there is a sound market-failure rationale for the policy that requires premarket approval?
Given that you believe there is no sound market failure rationale for the policy that requires pre-market approval, please explain why you do not oppose the policy. Much better access to information
Do you believe that consumers or patients systematically err when coping with uncertainties related to health and treatment? Most definitely.
In what ways does consumer or patient erring manifest itself? Sham treatments remain a big business.
Do you believe that doctors systematically err when selecting and prescribing therapies? If you include value (i.e., cost per successful therapy), then this occurs frequently.
In what ways does doctor erring manifest itself? In addition to costs we still see a lot of prescriptions for drugs that simply don't work or have much better alternatives.
Say the policy that requires pre-market approval was eliminated and, in its place, a policy was implemented allowing new pharmaceuticals/devices and initially classifying them as requiring a doctor’s prescription (pending a review process to consider dropping the prescription requirement). Do you think such a liberalized system would be superior to the current system? I don't think that individual physicians have the time to track down and evaluate whether a new drug offers a better alternative to existing therapies.
Do you believe that uncertainty per se constitutes a market failure? No, even the current system has uncertainty. The common occurrence of off-label prescribing relies on the possibility the drug offers better patient value.
How in your view does uncertainty per se constitute a market failure?
Knowledge is often said to have public-goods aspects. Imagine a new pharmaceutical being developed within the current regulatory system and brought all the way through to FDA approval. Do you think the policy that requires pre-market approval induces the generation of more knowledge about the new pharmaceutical than there would have been in the absence of the policy? Yes. Barriers to entry require the company to work harder to prove the benefits of their product.
As compared to the current system, would you favor making approval of a new drug automatic upon completion of the safety and efficacy testing processes specified by the FDA, regardless of what those testing results turned out to be? That depends on how the results of those processes get summarized, evaluated and communicated. Groups like the Cochrane Collaboration help us get closer to that possibility.
Relative to doctors and consumers, do you believe the government has superior ability to judge the safety and efficacy of pharmaceuticals (assuming, that is, that the government does not have exclusive access to certain research information)? Much better than individual doctors and consumers. But other groups (e.g., Cochrane, Drug Effectiveness Review Project, etc.) add additional expertise to the FDA review. I'll admit that I've been very impressed with the quality of the FDA expert reviews.
How would you describe or explain the government's superior ability to judge safety and efficacy? Compared to individual doctors and consumers that is their job.
As compared to the current system, would you favor a reform so that pharmaceuticals approved by the FDA counterparts in Europe, Japan, Canada, or Australia were automatically approved for the United States? Why not? They do a good job.
Which of the following describes the nature or source of the market failure that justifies the policy requiring pre-market approval? Presently, the market cannot force the drug companies to extensively test and communicate all results to the public.
Please describe the 'other' source of market failure that justifies the policy requiring pre-market approval.
Do you believe that consumers or patients systematically err when coping with uncertainties related to health and treatment? I know I have. New evidence leads to changed opinions. I still don't know if resveratrol (e.g., red wine) has a significant benefit.
In what ways does consumer or patient erring manifest itself? Homeopathy
Do you believe that doctors systematically err when selecting and prescribing therapies?
In what ways does doctor erring manifest itself?
Say the policy that requires pre-market approval was eliminated and, in its place, a policy was implemented allowing new pharmaceuticals/devices and initially classifying them as requiring a doctor’s prescription (pending a review process to consider dropping the prescription requirement). Do you think such a liberalized system would be superior to the current system? The choice of individual prescribers does not help us evaluate the benefits of a new drug.
Do you believe that uncertainty per se constitutes a market failure? No. Physicians that have good information make good decisions.
How in your view does uncertainty per se constitute a market failure?
If neither consumers nor doctors err systematically in these matters and uncertainty per se does not constitute a market failure, then in what sense do you believe that imperfect information is a source of the market failure that justifies the policy requiring pre-market approval? That has been the primary problem. But how do we create the incentives for physicians and consumers to access and evaluate good information?
In addition to systematic error on the part of consumers/doctors and/or uncertainty per se, is there any other sense in which you believe imperfect information to be a source of the market failure that justifies the policy requiring pre-market approval?
You indicated that public-goods aspects of knowledge do not justify the policy requiring premarket approval. Is that because you think such aspects are better addressed by subsidizing the generation of knowledge, e.g., via the National Institutes for Health? I have trouble believing that a single organization can guess right when prioritizing their research.
You indicated that public-goods aspects of knowledge are a source of the market failure that justifies the policy requiring pre-market approval. Do you think that this source of market failure would be better addressed with a policy that subsidizes the generation of knowledge, e.g., via the National Institutes for Health?
Imagine a new pharmaceutical being developed within the current regulatory system and brought all the way through to FDA approval. Do you think the policy that requires pre-market approval induces the generation of more knowledge about the new pharmaceutical than there would have been in the absence of the policy? Yes. Otherwise a lot of the knowledge would look like abstracts from early research.
How is it, then, that the public-goods aspect of knowledge provides a rationale for the current system?
As compared to the current system, would you favor making approval of a new drug automatic upon completion of the safety and efficacy testing processes specified by the FDA, regardless of what those testing results turned out to be? This might work if the results were readily available. But would advertising drown out the analysis performed by the third-party expert groups?
You indicated that a superior ability of government to assure the safety and efficacy of pharmaceuticals justifies the policy requiring pre-market approval. Does that superiority stem from the FDA having special expertise in evaluating safety and efficacy?
Why is it that doctors and consumers have inferior judgment in evaluating safety and efficacy? Lack of time, lack of information, lack of training.
Would you say that impartiality or commitment to the public good are sources of the government’s superior ability to assure safety and efficacy? I wouldn't call it impartial, just less partial.
In what ways does the FDA’s impartiality or commitment to the public good render it superior to doctors and patients in judging safety and efficacy?
What is the basis of government’s superior ability to assure safety and efficacy, if not the FDA’s special expertise, impartiality, or commitment to public good?
Prior to 1962, the FDA did not consider efficacy when making drug approval decisions. Doctors today are at liberty to prescribe drugs for “off-label” use—that is, for use where there has been no FDA evaluation of the drug’s efficacy. However, as part of the current pre-market approval process, the FDA requires proof of efficacy in the drug’s “on-label” use(s). Would you favor dropping efficacy requirements from the pre-market approval process? I want to know that. How else will we get that information?
Efficacy requirements were introduced in 1962. Do you believe that the pre-1962 record shows systematic failure in assuring efficacy? I'm still concerned about the post-1962 record.
What evidence can you cite for systematic failure in assuring efficacy prior to 1962?
Do you have any general comments about this questionnaire or further thoughts about the matters treated?

DMAA "Responds" to Business Week Article Slamming Disease Management

2010-02-12T10:36:00.000-05:00

The response was weak but did make a good point. The best example they could cite was a program that lowered co-payments to encourage better medication adherence. This was not the standard DM referred to in the article. But it does emphasize that low cost interventions to increase compliance can have a very favorable return on investment.

What Patient Characteristics Influence Use of Mail-Service Over Local Pharmacies?

2010-01-15T09:22:00.000-05:00

A recent article in the American Journal of Managed Care identified better compliance (84.7% vs 76.9%) in patients using mail-service rather than a local Kaiser pharmacy. However, the self-selected groups had much different characteristics such as race, socioeconomic deprivation score, Medicare versus commercial insurance and financial incentives to use mail-service. I am still not sure whether place of service matters in most situations. I think the services any pharmacy provides to improve adherence makes a bigger difference. These include reminders, compliance monitoring and notification, incentives and personal connections with a pharmacist.

When Generic Intros Drop Price by 60% Why Doesn't Utilization Increase?

2009-11-02T15:15:00.000-05:00

Real interesting report from the Manhattan Institute. They looked at generic introductions from 2000-2004 and found essentially no change in utilization at the specific drug or drug category level. Lots of data in this report and I strongly recommend you take a look. They even looked at sampling and the impact of therapeutic substitution following generic introductions (e.g., impact on Lipitor when Zocor went generic).

"And then she presented this card"

2009-10-22T12:20:00.000-04:00

NPR reports on the use of drug company coupons to subsidize the cost of brand drug co-payments. But what's the big deal if the drug company makes up the difference between their drug and the generic alternative? Here's the payments for the Solodyn example:

Patient: $10
Drug company (Medicis): $154.28
Insurance: $462.84 (est.)

Most of the insurance payment goes back to the drug company. They probably made over $300 for a one-month supply of a once-daily version of generic minocycline (~$40). But my favorite part of the story was when the doctor didn't offer the savings card until AFTER the patient complained about the price. How many people get to pay the $154 or even the full price?

Some plans now use reference pricing to counter these efforts. This requires the patient to pay the full amount above what the insurance would have paid for the higher value alternative. Another method would require the patient to pay the full amount up front, like indemnity insurance, then get reimbursed for the covered amount. This helps patients understand the true costs of their treatment.

What do you get for an extra $600 per month? Because Solodyn results in lower blood lets it MAY cause less vestibular effects (e.g., dizziness, tinnitus). Maybe that extra money will go towards a direct comparison to prove that possibility.

PBMs Still Looking Out For #1?

2009-10-21T16:10:00.000-04:00

Therapeutics Daily reports on physician complaints related to a letter sent by CVS Caremark promoting the use of Cymbalta for fibromyalgia. Here's what a Cochrane Review said about Cymbalta for fibromyalgia:

"No direct comparison has been performed between duloxetine and any of these other drugs. As yet it is not clear whether the use of duloxetine is cost effective when compared to the other drugs already in use."

It doesn't sound like the letter offers good information on selecting the highest value medication. So they may not be looking out for plans and patients as #1. But I also wonder whether the revenues from this letter would be offset by their lost profit margins if utilization moved away from generics and to brand-name drugs. Both retail and mail-service pharmacies tend to make more money on generics. Is this a case of shooting everyone in the foot?

Still Not Sure Re-Importation Is A Good Idea (Yet)

2009-10-09T07:11:00.000-04:00

From October 8th Time article on counterfeit drugs:

"The problem is not limited to poor countries, however. When Pfizer recalled 120,000 packs of its cholesterol drug Lipitor in Britain in 2005 after it discovered a counterfeit version, it found that 60% of all the returned packs were fakes. Jacques Franquet, who heads security operations for the French drugmaker Sanofi Aventis, says his teams routinely find fake versions of about 15 of the company's drugs worldwide."

What I can't find out is whether the costs of pedigree programs (e.g., RFID tracking) would be offset by the savings associated with greater re-importation. I can't imagine that pharmaceutical companies wouldn't find a way to adjust pricing on existing or (most likely) newly launched medications to maintain their revenues.

Small Benefit, Positive ROI for Automated Adherence Reminder Calls?

2009-10-07T08:41:00.000-04:00

George Van Antwerp of Silverlink pointed me to this report on the impact of an automated calling service on medication compliance. Overall medication compliance increased by 2%. This may not sound like much but it probably has a positive return on investment (ROI). Basically, one reduced hospitalization due to improved compliance can pay for a lot of low cost interventions. I hope someone publishes the actual ROI for this program.

Can Patient Counseling Lower Adherence?

2009-10-01T12:48:00.000-04:00

The abstract of a recently published article, "A systematic review of adverse events in placebo groups of anti-migraine clinical trials", stated:

"We found that the rate of adverse events in the placebo arms of trials with anti-migraine drugs was high. In addition, and most interestingly, the adverse events in the placebo arms corresponded to those of the anti-migraine medication against which the placebo was compared. For example, anorexia and memory difficulties, which are typical adverse events of anticonvulsants, were present only in the placebo arm of these trials. These results suggest that the adverse events in placebo arms of clinical trials of anti-migraine medications depend on the adverse events of the active medication against which the placebo is compared. These findings are in accordance with the expectation theory of placebo and nocebo effects."

Could counseling on all common side effects lower adherence by increasing the incidence of adverse events? I could not find any research on this subject. Therefore, I likely would draw the line, as I actually did in the USP-DI side effects listing below, at reviewing the adverse events that require medical attention. I am not sure whether I would want to exclude information from the printed counseling materials.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Most side effects of sumatriptan are milder and occur less often with thetablets than with the injection. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Stop using this medicineand check with your doctor immediately if any of the following side effectsoccur:

Rare

Chest pain (severe); changes in skincolor on face; convulsions (seizures); fast or irregular breathing; puffinessor swelling of eyelids, area around the eyes, face, or lips; shortness of breath, troubled breathing, or wheezing

Check with your doctor right away if any of the following side effects continuefor more than 1 hour. Even if they go away in less than 1 hour, check with your doctor before using any more sumatriptan ifany of the following side effects occur:

Less common

Chest pain (mild); heaviness, tightness,or pressure in chest and/or neck

Also check with your doctor as soon as possibleif any of the following side effects occur:

Less common

Difficulty in swallowing; pounding heartbeat; skin rash, hives, itching, or bumps on skin

_____________________________________________________________________________________________________________

Other side effects may occur that usually do not need medical attention.Some of the following effects, such as nausea, vomiting, drowsiness, dizziness,and general feeling of illness or tiredness, often occur during or after amigraine, even when sumatriptan has not been used. Most of the side effectscaused by sumatriptan go away within a short time (less than 1 hour afteran injection or 2 hours after a tablet). However, check with your doctor ifany of the following side effects continue or are bothersome:

More common

Burning, discharge, pain, and/or soreness in the nose; burning, pain, or redness at place of injection; change in sense of taste; discomfortin jaw, mouth, tongue, throat, nose, or sinuses; dizziness; drowsiness; feeling of burning, warmth, heat, numbness, tightness, or tingling; feeling cold, ?strange,? or weak; flushing; lightheadedness; muscle aches, cramps, or stiffness; nausea or vomiting

Less common or rare

Anxiety; general feeling of illnessor tiredness; vision changes

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.