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In New Jersey, a bill (A2477) authorizing pharmacists filling a prescription for a biological medication to select an interchangeable biological product, was signed into law…A substitution cannot be made if the prescriber indicates that there shall be no substitution. The law requires the New Jersey State Board of Pharmacy to maintain a link on its website to FDA’s current list of interchangeable biological products. Further, the law requires a pharmacist or designee to notify the prescriber of the biological product dispensed, including the name of the product and the manufacturer, within five days…The pharmacist is also required to record on the prescription label, and record of dispensing, the product name of the interchangeable biological product, followed by the words “Substituted for” and the name of the biological medication for which the prescription was written, and the manufacturer of the interchangeable biological product.

Medicines Patent Pool…announced its first licence for a hepatitis C medicine, signing an agreement with Bristol-Myers Squibb for daclatasvir, a novel direct-acting antiviral that is proven to help cure multiple genotypes of the HCV virus. The royalty-free licence will enable generic manufacture of daclatasvir for sale in 112 low- and middle-income countries (LMICs)...Nearly two-thirds of all patients living with hepatitis C in the LMICs reside in the territory covered by this agreement…Hepatitis C is a major public health threat affecting up to 150 million people globally, with the vast majority living in low- and middle-income countries. Earlier this year the World Health Organization added several new hepatitis C treatments, including daclatasvir, to its Essential Medicines List, underscoring the urgent need to promote equitable access to innovative medicines.

Hundreds of genetically modified mosquitoes that are incapable of spreading the malaria parasite to humans have been created in a laboratory as part of a radical approach to combating the disease…The move marks a major step towards the development of a powerful and controversial technology called a “gene drive” that aims to tackle the disease by forcing anti-malarial genes into swarms of wild mosquitoes…mosquitoes were engineered to carry genes for antibodies that target the human malaria parasite...When released into the wild, researchers believe the modified insects will breed with normal mosquitoes and pass the anti-malarial genes on to their young, making an ever-increasing proportion of future generations resistant to the malaria parasite…To track which insects inherited the antibody genes, the scientists added a tracer gene that gave carriers red fluorescent eyes…Concern that drug and insecticide resistance are eroding recent successes in managing malaria has drawn attention to alternative approaches, including the use of genetically modified mosquitoes.

..FBI…announced a $390 million settlement against NOVARTIS...in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade (deferasirox) and Myfortic (mycophenolic acid)…two specialty pharmacies, Bioscrip, Inc. and Accredo Health Group, agreed to pay a total of $75 million to resolve federal and state claims against them based on the same allegations...today’s settlement, the federal and state governments will recover $465 million in total based on the kickback allegations in this lawsuit…a whistleblower, and asserted that NOVARTIS violated the False Claims Act and the Anti-Kickback Statute…by giving kickbacks to specialty pharmacies in return for recommending Exjade…and Myfortic…With respect to Exjade, the Government alleged that NOVARTIS gave kickbacks in the form of patient referrals and rebates to Bioscrip and Accredo to induce those pharmacies to recommend Exjade refills…the Government alleged that, to increase Exjade sales, Novartis incentivized and pressured the pharmacies to emphasize Exjade’s benefits to patients while understating the drug’s serious, potentially life-threatening, side effects. With respect to Myfortic, the Government alleged that NOVARTIS gave rebate contracts to specialty pharmacies to induce the pharmacies to recommend to doctors that they switch patients to Myfortic from competitor drugs.

Centers for Medicare and Medicaid Services have finalized a rule regarding the Medicare reimbursement methodology for biosimilar products. Biosimilars…approved …as being “highly similar” to a specific biologic medication…patients may respond differently to the reference product and the biosimilars...there is now a debate as to whether or not biosimilars should be paid with a single billing code based on the ASP (Average Sales Price) of all biosimilars for a single reference product, as has been finalized by CMS, or the ASP for each individual biosimilar, separately from any other biosimilar of the same reference product…Economic arguments and patient safety concerns may support the latter, though the statutory text regarding this matter is somewhat ambiguous…the decision over how biosimilars…should be reimbursed…should be determined by economic principles based on the value of the medication to patients and without putting patient safety and access to such products at risk. If the statutory text does not clearly provide for the favorable regulatory outcome of these factors, it should be amended.

Take that, Theranos!..Clearly determined to offer direct-to-consumer lab testing through pharmacies, grocery chain Safeway seems to be shaking off the reported demise of a partnership with the not-so-revolutionary-after-all testing company (Theranos)… Sonora Quest Laboratories, a joint venture of Quest Diagnostics and Phoenix’s Banner Health, has opened its first testing center at a Safeway in...Scottsdale, Arizona. A second one will open next week in an upscale part of Phoenix...

Treating hepatitis C with expensive new medicines at the earliest signs of liver damage improves patients' health and is also cost-effective, a new computer simulation suggests…"Going into this, I expected to find it did make sense to wait until there was a limited amount of liver disease, but what we found to our surprise is that it makes sense to start treatment at the earliest change in the liver,"…researchers created a simulated model to study the cost-effectiveness of a medicine…The imaginary subjects…of varying ages and with various stages of liver damage… While treating all stages of liver disease was cost-effective, the up-front cost is substantial. Treating half of those with hepatitis C would cost about $53 billion. That cost can be brought down if the price of the drug also decreases, the researchers write…"I think a key policy point here is that cost-effectiveness is important and this study shows that, but a next and important step is...to address the cost of the drug,"

With rising drug prices such a hot topic here, drug makers and health insurers are both coming under heavy fire…So much fire that they’re considering a radical response: working together…After years of relentlessly attacking one another, leaders of the pharmaceutical industry and the health insurance lobby are considering — warily — cooperating to shape any federal legislation that emerges from the public outrage at the high cost of medications…The two powerful lobbies remain fundamentally at odds in their agendas: In the most basic terms, drug makers want to make as much money as they can for their medicines, and insurance companies want to pay as little as possible…both are under a lot of pressure from Congress and the Obama administration to figure out a unified response to high drug prices...Here’s a guide to the key players — and their agendas.

• Health insurers…want to work with drug makers, but they expect major concessions.
• Drug makers…“Medicines that truly represent value should merit a larger price.”
• So what now?

Old habits die hard, though. Even as leaders in both lobbies talk about a kumbaya moment, shots are still being fired. Earlier this month, a drug industry-backed group put out a report accusing health insurers of “hiding profits to justify raising prices.”...Just a few hours later, Tavenner’s group (health insurers)released a report of its own, asserting that drug companies “continue to demand a blank check, driving up costs across the board for everyone.”

California and Oregon…will soon make access to birth control easier for millions of women by allowing them to obtain contraceptives from pharmacists without a doctor’s prescription…Most Western countries require a doctor’s prescription for hormonal contraceptives…but starting sometime in the next few months, women in California and Oregon will be able to obtain these types of birth control by getting a prescription directly from the pharmacist who dispenses them, a more convenient and potentially less expensive option than going to the doctor…Pharmacists will be authorized to prescribe contraceptives after a quick screening process in which women fill out a questionnaire about their health and medical histories…pharmacists’ organizations, plan to lobby for it across the country…One unanswered question, however, is whether insurers will pay for the time pharmacists spend reviewing women’s questionnaires or helping evaluate options. To cover that cost, some pharmacists may charge fees...The laws in Oregon and California differ in some ways. California’s has no age restriction; the Oregon law requires that teenagers under 18 obtain their first contraceptive prescription from a doctor. In California, pharmacists will also most likely have to take women’s blood pressure for contraceptives containing estrogen.

All clinicians should prescribe generic medications whenever possible as a way to improve adherence to therapy and clinical outcomes while containing costs, “While the use of generic drugs has increased over time, clinicians often prescribe more expensive brand name drugs when equally effective, well proven, and less expensive generic versions are available,”…“The use of generic drugs is a High Value Care way to improve health, avoid harms, and eliminate wasteful practices.”… “ACP (American College of Physicians) recognizes that there are situations where generic substitution is not possible and the use of brand name drugs is clinically appropriate,”…Some of the underuse of generic medications is likely the result of patient and physician perceptions about the safety and a perceived lack of efficacy of the lower cost options. Patients may also associate the lower price of generics with lower levels of effectiveness… Public awareness and advertising campaigns similar to those used for brand name drugs might help to alter patient perceptions about generics…