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Valeant Pharmaceuticals rout put specialty pharmacies under an unwelcome spotlight. But though Valeant's own close relationship with Philidor RX may be an unusual one--a host of Big Pharma and Big Biotech companies have now denied similar arrangements--tight links between drug marketing and specialty pharmacies are increasingly common industry wide…Valeant is hardly alone in depending on a specialty pharmacy for sales success. What began as a technique for getting "complex, costly drugs"--often orphan meds for rare diseases--to the appropriate patients has become a broadly used marketing technique…Pharma's pricing and marketing moves are going to stay on center stage for some time.

Food and Drug Administration recently approved…PCSK9 inhibitors…These novel biologic agents offer the promise of reductions in blood cholesterol levels. This broad indication sets the practice of cardiology on a collision course with specialty pharmaceutical pricing models…At its core, the current pricing model for these products is driven by a transformation in the pharmaceutical industry, whereby 84% of prescriptions are filled with generic products and follow-on biologics have the potential to disrupt many established markets and firms…for most firms, future revenue expectations hinge on novel therapies…without the potential for outsized returns, capital might not be available for early innovation in biotechnology. Pricing pressure on innovative products would drive a fundamental restructuring of the industry and further increase the financial challenges of bringing scientific innovations to the market. It is important that we manage these downside risks carefully as we work toward a more sustainable pricing model in this market.

...House of Representatives’ Committee on Energy and Commerce Subcommittee on Health convened a hearing called "Examining Medicare Part D Medication Therapy Management Program."...aimed at figuring out the best ways to strengthen MTM model as the Centers for Medicare and Medicaid roll out an overhaul… Rite Aid’s director of field clinical services… spoke in favor of expanding MTM…and highlighted recent efforts...which include the introduction of a bill…the Medication Therapy Management Empowerment Act that would increase access to MTM for patients with such chronic conditions as diabetes, cardiovascular disease, high cholesterol and COPD…given community pharmacist’s unique role as an easily accessible healthcare provider, they could be at the center of the expansion of MTM programs.

...the IMS Institute has just snuck out an interesting report: Emergence and Impact of Pharmacy Deductibles: Implications for Patients in Commercial Health Plans. The report’s overarching theme is unsurprising: Higher out-of-pocket costs reduce patients’ adherence to drug therapy and increase prescription abandonment rates…The report’s major contribution, however, links the growth in pharmacy deductibles to manufacturers’ copayment offset programs, which cover a beneficiary’s out-of-pocket costs for a brand-name drug. High deductible plans are shifting costs from payers to consumers and—in many cases—back to manufacturers.

..Imprimis says it will offer a compounded drug that includes Daraprim's active ingredient--pyrimethamine--in capsules starting at $99 for a 100-count bottle. The company is also starting a program to work with payers, pharmacy benefits managers and purchasing groups to offer patient-specific formulations "at prices that ensure accessibility."…The compounded drug isn't an exact copy; it also includes the ingredient leucovorin, which…helps to combat pyrimethamine's negative effects on bone marrow…After the meningitis outbreak linked to the New England Compounding Center, new regulations tightened up on distribution of compounded drugs, which aren't specifically approved by the FDA. Compounded meds can only be dispensed on specific prescriptions for specific patients, rather than distributed in bulk as FDA-approved products are...

..Duexis is a combination of two old drugs, the generic equivalents of Motrin and Pepcid…If prescribed separately, the two drugs together would cost no more than $20 or $40 a month. By contrast, Duexis, which contains both in a single pill, costs about $1,500 a month…Needless to say, many insurers do not want to pay for Duexis. Yet sales of the drug are growing rapidly, in large part because its manufacturer, Horizon Pharma, has figured out a way to circumvent efforts of insurers and pharmacists to switch patients to the generic components, or even to the over-the-counter versions…It is called "Prescriptions Made Easy." Instead of sending their patients to the drugstore with a prescription, doctors are urged by Horizon to submit prescriptions directly to a mail-order specialty pharmacy affiliated with the drug company. The pharmacy mails the drug to the patient and deals with the insurance companies, relieving the doctor of the reimbursement hassle that might otherwise discourage them from prescribing such an expensive drug...Horizon is not alone. Use of specialty pharmacies seems to have become a new way of trying to keep the health system paying for high-priced drugs.

A…nurse who admitted taking kickbacks from a drug company that makes…Subsys (fentanyl sublingual) was pressured by sales representatives to increase her prescribing "so that the Subsys numbers would also increase,"…federal prosecutors charged that Heather Alfonso "continued to increase her prescribing of Subsys and to find more patients for whom she could prescribe the drugs" in exchange for a series of $1,000 kickbacks, totaling $83,000, from the company, Insys Therapeutics…the…narcotic is approved only for cancer patients, some of the patients given Subsys by Alfonso "did not have a cancer diagnosis,"...But "prior authorizations" submitted on behalf of patients falsely represented that they had cancer, misleading insurers into paying for the drug…She…was the highest prescriber in Connecticut in 2013, writing $2.7 million in prescriptions.

In their Perspective article…Avorn and Kesselheim argue that the 21st Century Cures Act, which is currently being debated in Congress, would lower the regulatory standards of the Food and Drug Administration by giving it greater discretion to approve drugs on the basis of less rigorous data…the legislation would authorize the FDA to "rely" on observational analyses, which are less rigorous than randomized controlled trials. But the Cures Act does not diminish the FDA's standards for requiring that new medical products are safe and effective. Rather, it recognizes that recent developments in genomics, systems biology, electronic data systems, and other fields can provide additional tools and resources to support better premarketing and postmarketing regulation and more efficient development of drugs and medical devices…Better evidence and up-to-date regulatory science are the best foundation for regulatory decisions and meaningful progress in biomedical innovation. They are also the best way to avoid turning back the clock on new opportunities to develop safe and effective treatments for unmet medical needs...

There is a new price surge in the pharmaceutical industry—for a limited number of government-issued vouchers that drug makers… are buying to speed products to market…vouchers require the FDA to shorten its decision deadline to six months… Because companies can also sell the vouchers, a lucrative secondary market has emerged. AbbVie agreed in August to pay $350 million for a voucher from United Therapeutics Corp. ,which received it for developing a pediatric cancer treatment…the voucher program is attracting…criticism…These programs allow sponsors to ‘purchase’ a priority review at the expense of other important public health work in FDA’s portfolio… such as reviewing applications for drugs that treat more serious conditions...Adding to the escalating prices: the vouchers have a scarcity value because only seven have been issued…

A new report from the Centers for Disease Control and Prevention is shining light on steps that can be taken to prevent opioid abuse and misuse… CDC found that prescribing practices between states vary drastically… demographic differences between states do not entirely explain the variation...the CDC notes that the real way to fix the issue is to improve prescribing practices…A more comprehensive approach is needed to address the prescription opioid overdose epidemic, including guidance to providers on the risks and benefits of these medications…One of the largest contributors to opioid abuse is overprescribing done by a small number of prescribers whose prevalence is different between states…