drug pricing Archives - Medical Design Sourcing

Could Wegovy’s cardiovascular label expansion be a catalyst for GLP-1 obesity drug coverage?

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The recent FDA approval of a cardiovascular risk reduction indication for Wegovy (semaglutide) could point toward a significant opportunity for pharma companies seeking to reshape payer perceptions and expand coverage for next-gen metabolic therapies. This regulatory shift, allowing Wegovy to be prescribed for reducing the risk of major adverse cardiovascular events such as heart attack and stroke in addition to weight loss, aligns with mounting payer pressure to address the worsening obesity epidemic, which could impact 60% to 80% of the population of Western nations by the middle of the century. The dynamic has the potential to break down long-standing reimbursement barriers for effective yet costly medications.

Payers reckoning with the complex economics of obesity

There were already signs of change. While around 25% of employers provided coverage for GLP-1 drugs like Wegovy and Ozempic …

Is the new $15,900 postpartum depression pill worth it?

Zuranolone molecule image from PubChem

Sage Therapeutics has pegged the wholesale acquisition price of the oral postpartum depression (PPD) drug Zurzuvae (zuranolone) at $15,900 for a 14-day course of the therapy. The drug, co-developed by Biogen, won the FDA green light in August. The companies plan on launching the drug in December. The DEA has classified zuranolone as Schedule IV, which mostly includes benzodiazepines. That status could influence prescriber and patient perceptions concerning the drug’s safety profile and potential for abuse. The formulary review process for Zurzuvae, critical for insurance coverage, will occur throughout 2024.

Sage had initially aimed to price Zurzuvae under $10,000, but its failure to win approval earlier this year for zuranolone for major depressive disorder altered its pricing strategy.

Zurzuvae postpartum depression cost in context

The wholesale acquisiti…

PBMs increasingly under fire in drug-pricing battle

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As the national debate over drug pricing ramps up, Pharmacy Benefit Managers (PBMs) find themselves squarely in the spotlight. PhRMA, which has also criticized hospitals for marking up drug prices by as much as 500%, launched a seven-figure ad campaign targeting proposals in Congress to lower drug prices.

PhRMA, which counts companies such as Pfizer, Novartis, and Merck & Co. as members, finds itself on the defensive as the federal government and the public demand greater transparency and accountability in drug pricing. A recent study from KFF found that 82% of adults believe the cost of prescription drugs is unreasonable.

As prices for new drugs continue to soar, PhRMA is taking a proactive approach in its messaging. Instead of touting innovation as it has done in the past, the ____ is ramping up attacks on intermediaries like PBMs as driving up costs.

For instance, in a recent PhRMA ad titled…

Prices of top 25 Medicare Part D drugs more than doubled since market entry; AARP offers new insights in drug pricing report

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Medicare Part D drug prices have seen a significant surge in recent years. The price of the arthritis drug Enbrel has soared 701% since its launch in 1998, and the diabetes drug Januvia has jumped 275% since its debut 2006. All in all, the average price increase for the 25 brand-name drugs with the highest Medicare Part D spending in 2021 was 226%, noted AARP in a recent drug pricing report.

Such attention-grabbing stats aren’t isolated cases, but part of a bigger picture. Almost 60% of the current list price for the top 25 drugs is a result of price increases post launch. “On average, the prices of the 25 top Medicare Part D drugs have more than tripled since they first entered the market,” said Leigh Purvis, director, health care costs and access at AARP, in a media briefing. “Some of the prices are more than eight times higher than they were when they launched.”

The economic…

Big Pharma, it’s time to talk: Investors demand transparency on patent thickets

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Pharmaceutical companies are running into pushback for their “patent thicket” tactics, designed to maintain exclusive rights and delay cheaper generics. The Financial Times reported that an ethical investor coalition is pushing for greater transparency and urging major drug makers to disclose their patent strategies.

Unraveling the patent thicket mystery

Patent thickets are a common intellectual property tactic in pharma. Companies file numerous patents beyond the primary one for a specific compound. Critics say this cunning approach stalls the introduction of generics even after the 20-year exclusivity of primary patents expires. Consequently, drug prices remain high, and affordable medications remain out of reach for many.

Drugs like Humira (adalimumab) and Keytruda (pembrolizumab), for example, have experienced extended periods without biosimilar or generic competition, lea…

Specialty pharmacy association backs bipartisan drug pricing plan

This week, bipartisan lawmakers in the House and Senate introduced legislation known as the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. The bill would make changes to fees tied to direct and indirect remuneration, or DIR, under Medicare Part D.

The National Association of Specialty Pharmacy (NASP) released a statement applauding the proposed legislation stating that it projects specialty pharmacy patient needs.

“Advancing this legislation will be a victory for patients, specialty pharmacies, the Medicare program and ultimately taxpayers,” said Sheila Arquette, NASP President and CEO, in a statement. “High drug costs and anticompetitive business practices that threaten specialty pharmacy’s ability to care for their patients risks lives and significantly drains Medicare and taxpayer resources.”

In related news, more than 130 healthcare organizations praised the introduction of the Pharmacy and Medically Underserved Areas Enhancement Act (S. 1362, …

Medicare drug pricing cuts face long odds, expert says

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One of the chief objectives of various drug pricing reform efforts in recent years has been reducing Medicare costs for patients and the federal government.

Last year, CMS highlighted reductions in prices for insulin and other drugs covered under the Medicare prescription drug benefit (Medicare Part D). But it is more likely that Medicare drug prices for consumers will increase in coming years, according to Ron Elledge, a Medicare consultant at MedicarePlans.com.

“If the new administration returns to some form of Obamacare as predicted, and the Medicare age decreases to 60 years as President Biden desires, the premiums for Medicare Part D will most likely escalate and the cost of drugs for all will see an unpredictable increase,” he said. “History demonstrates that when the government takes a greater hand in the regulation…

Unclear path for drug-pricing reform after Dem sweep

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With Democrats having gained control of the Senate and the presidency, some form of drug-pricing reform is likely. But with the raging COVID-19 pandemic and ongoing threats to the Affordable Care Act, Democrats are more likely to focus on those issues in the near term, according to Barrett Thornhill, a partner at the public affairs firm Forbes Tate in a call with UBS analysts.

The political dynamics of the House is one challenge. Even though Democrats have narrow control of the House, they also have an increasingly vocal progressive wing. For that reason, bipartisan healthcare policy from the Senate could “actually have some trouble when it goes to the House because it’s not left enough,” Thornhill said.

COVID-19 itself has stymied prior legislative attempts at drug-pricing reform, while President Trump’s executive orders face ongoing legal challenges.

Significa…