Pharma Prepares for Legal Battle Over US Drug Price Reform
As the upcoming Medicare drug pricing negotiations loom large over the industry, pharma companies are preparing to challenge the government in court. One sticking point for the companies is that they aren’t allowed to talk about negotiations, facing heavy fines for any infractions. Another issue is how drugs to be negotiated are chosen.
EQRx Dashes Plans to Drive US Drug Pricing Reform
EQRx is moving on from its previous goal to change the drug pricing landscape in the US, letting go of over half its employees in the process. The company’s mission was to cut costs through developing drugs in categories with known safety profiles, cutting research timelines and expenses by up to 50%. They are now moving towards a market-based pricing strategy moving forward.
India Negotiating Generic Export Prices with UAE
The Indian government is currently negotiating drug external reference pricing (ERP) with the United Arab Emirates (UAE). To cap drug prices, the UAE uses an ERP based primarily on wealthy European nations and the US. Officials contend that this practice and vaccine import rules that exclude Indian generics barriers to exporting generics and vaccines.
US Inflation Reduction Act Places More Financial Liability on Insurers and Drugmakers
Speakers at a panel at the 2023 Specialty Pharmacy Summit in Las Vegas, Nevada discussed how provisions in the Inflation Reduction Act, passed in the US last year, would pass more liability onto drugmakers and payers. One reason for this are inflation-based rebates that drugmakers must pay if they raise the price of drugs higher than inflation for Medicare Part B and D plans.
US PBM Bill Markup Hearing Postponed Until May 11th
US Senators were geared up for a hearing to markup a bill targeting practices of the pharmacy benefit manager (PBM) industry that are alleged to be anticompetitive and drive up drug prices. However, this meeting has been delayed until May 11th so that the markup can occur after a May 10th hearing featuring testimony from major pharma and PBM leaders.
External Reference Pricing Doesn’t Lower High Drug Launch Prices
A recently published paper in Health Policy OPEN finds that external reference pricing (ERP) policies don’t result in lower drug launch prices. The study, which investigated 100 high-priced drugs, also reported that ERP policies slowed the launch of new drugs, lowering the odds of them hitting the market within 9 months of approval by 73%. ERP policies were, however, associated with decreases in annual cost.
US Senators Weighing Approaches to Lowering Insulin Prices for All
As US Senators continue to debate over plans to lower insulin prices for all Americans, two bills have taken the forefront. One, by Sen. Susan Collins (R-ME) and Sen. Jeanne Shaheen (D-NH) would cap monthly cost-sharing at 25% of list price or $35. It would also force pharmacy benefit managers (PBMs) to make sure 100% of manufacturer rebates and discounts go to payers.
Pharma Already Bristling at Parts of EU Drug Overhaul
As the EU preps for a massive pharma regulation overhaul, industry groups have already begun levelling complaints. The reforms include simplifying the approval process, cutting approval timelines, and reducing exclusivity periods from 10 years to 8 years for new drugs, the key sticking point for pharma companies.
Paying for Legal Psychedelic Therapeutics in Australia
This summer, providers in Australia can legally prescribe psychedelics, MDMA and psilocybin, to patients suffering from post-traumatic stress disorder (PTSD) and depression that has not responded to other treatments. How these drugs will be paid for, however, is still up in the air. Due to a lack of cost-effectiveness analysis, it is unclear whether the therapeutics will be publicly subsidized.
UN Negotiating Price of Takeda’s New Dengue Vaccine
The World Health Organization’s (WHO’s) Pan American Health Organization (PAHO) is working with Takeda to negotiate pricing for the manufacturer’s new dengue vaccine Qdenga, the only one for the widespread illness. A key strategy being proposed is that large nations can pool their resources to purchase the vaccines in bulk at a lower price.
US Congress Continues Push for Lower Prescription Drug Prices
Members of the US Congress aren’t slowing down in the effort towards lowering prescription drug prices, following last year’s Inflation Reduction Act that established the upcoming Medicare drug price negotiations. One bill put forward by Democrats would shorten the timeframe before a drug can be negotiated. A bipartisan effort led by Bernie Sanders (I-VT) and Bill Cassidy (R-LA) will propose four bills related to reducing high drug prices.
Low Value, High Prices: Which Therapeutics Are Worth It?
Two recent value-assessment analyses found that many of the highest priced drugs in the US do not deliver enough beneficial effects to justify their list price. The first analysis came from the Institute for Clinical and Economic Review (ICER), which showed that the newly approved Alzheimer’s drug lecanemab was almost 20% higher than the maximum justified cost based on potential therapeutic benefits. The second analysis was published recently in JAMA examined Medicare spending on the top-selling prescription name brand drugs.
US House Committee to Hold PBM Hearing
Today, April 26th, a representative for the pharmacy benefit manager (PBM) industry will speak before the US House Energy and Commerce Health Committee in a hearing focusing on improving transparency and countering anti-competitive practices. The industry, to be represented by Kristen Bass of the Pharmaceutical Care Management Association (PCMA), has faced significant public and congressional scrutiny in recent years over allegations that their processes are opaque and push smaller pharmacies out of the market.
US Democrats Introduce Bill to Expand Medicare Prescription Drug Price Negotiations
A group of 21 US Democrats introduced a new bill that seeks to strengthen the upcoming Medicare pricing negotiations with the Centers for Medicare and Medicaid Services (CMS) instantiated by the Inflation Reduction Act. The bill, if passed, would shorten the timeframe for drug pricing negotiations to begin to 5 years, a significant departure from the 9 years currently established for small molecule drugs and the 13 years set for biologics.
The Fight Between Pharma and CMS Over Drug Pricing Reform Has Only Just Begun
Despite efforts by the pharma industry to stop it, Medicare prescription drug pricing negotiations from the US Inflation Reduction act still loom on the horizon. As a result, the industry is shifting its approach, now focusing on changing the law to its favor. Although pharma is putting energy into lobbying, litigation is soon to come.
AHIP Launches Campaign Tearing into Pharma for Drug Prices
AHIP, representing members of the US health insurance industry, is targeting pharma in its latest ad campaign. The campaign lays the blame for high prescription drug prices at pharma’s feet, highlighting anti-competitive practices, unjustified price hikes, and high profit margins for the largest pharmaceutical companies. However, pharma argues that payers themselves contribute to the problem.
Generics Group Wants in On UK Voluntary Scheme Negotiations
Around 40% of drugs covered by the UK’s voluntary drug revenue rebate system, the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), are generics and biosimilars. Because of this, the British Generics Manufacturers Association (BGMA) wants in on deliberations just like the organization representing branded medications, the Association of the British Pharmaceutical Industry (ABPI).
Relentless Health Value Podcast: Talking Medicare Drug Pricing Negotiations with Dr. Peter Neumann
In the latest episode of the Relentless Health Value podcast, host Stacey Richter sits down with Peter Neumann, ScD, of the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts University to discuss upcoming Medicare drug pricing negotiations. The two discuss how pricing negotiations will account for value and what effects they will have on drug prices for patients.
PhRMA Not a Fan of CMS Drug Price Negotiation Plans
Just as the US Centers for Medicare and Medicaid Services (CMS) closed its public comments for the initial draft guidance for its upcoming Medicare drug price negotiations process, the pharma industry group PhRMA has laid out its complaints in a 76-page letter delivered last week. The comment window, only one month long, was a sticking point for the group.
US Senate Finance Committee Unveils Plan to Regulate PBMs
A group of US senators in the Senate Finance Committee have released their plan to implement regulation targeting the pharmacy benefit manager (PBM) industry. The plan proposes changing how PBMs get compensated for drug sales, increasing transparency, and holding them financially and legally accountable for violations.
Examining Why Major Insulin Manufacturers Dropped Insulin Prices
In the months following the US Inflation Reduction Act capping the price of insulin for Medicare recipients, three of the largest insulin manufacturers cut their prices for the drug. Leemore Dafny, PhD, broke down why the pharma giants made this decision. One key reason put forward by Dafny was the concept of corporate shaming.
PhRMA Calls Foul on CMS Policy to Destroy Documents After Price Negotiations
The latest guidance from the US Centers for Medicare and Medicaid Services (CMS) contains a clause that states that manufacturers must destroy all documents from the agency within 30 days after a therapeutic is no longer considered a selected drug. PhRMA, a major industry group, claims this practice is unconstitutional and overreaching, making the process less transparent.
Biden Administration to Provide Free COVID-19 Vaccines to Uninsured People
The Biden administration is finalizing its plan to make COVID-19 vaccines, tests, and treatment free for uninsured people as the vaccines enter the commercial market. Once fully commercialize, prices for the mRNA-based shots from Moderna and Pfizer/BioNTech are set to spike to $100+. To curb this, the administration will prepare a stockpile of vaccines and therapeutics.
Making Naloxone OTC Doesn’t Go Far Enough
Last month, the US Food and Drug Administration (FDA) approved the over-the-counter (OTC) sale of naloxone, a drug commonly known as Narcan that reverses opioid overdoses instantly. The move was hailed by patient advocates, but many feel that OTC access is not enough to get the drug in the hands of those who need it. One key sticking point is the high cost per dose for name brand Narcan.
Cigna PBM Announces New Pricing Strategy
Cigna has announced a new pricing plan for its pharmacy benefit manager (PBM) arm that it promises will lead to increased transparency. The move comes as the PBM industry faces increasing public scrutiny over its lack of transparency and allegations of anti-competitive practices that drive up drug prices for patients and payers.
