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Pricing Debate

Set Alert for Pricing Debate

BCMA Drug Prices For Multiple Myeloma Don't Match Their Benefit, ICER Concludes

Despite the net health benefits of Abecma, the price is too high, while Blenrep has low long-term value for the cost, according to ICER's benchmarks.

Cost Effectiveness Pricing Debate ImmunoOncology

Latest From Pricing Debate

Aduhelm Shockwaves Will Reverberate Across Industry

The butterfly effect is an elegant analogy to describe the seemingly unpredictable and far-reaching implications of a relatively small and inconsequential event. The FDA’s approval of Aduhelm is not so much a butterfly gently flapping its wings, but rather a sonic boom emanating from a jet engine. Most immediately, it provides a new therapeutic option for millions of patients in dire need of hope, vindicating Biogen’s faith with a revenue stream running into many billions of dollars. Longer-term the reverberations may be felt across the entire industry, throwing into question the evidentiary requirement for drug development.

Approvals Clinical Trials

Aducanumab And The US Pricing Debate: A New Hook, But Still A Fuzzy Picture

Some Democratic senators are not fans of FDA’s approval of Biogen/Eisai’s Aduhelm, and are even more critical of the price of the Alzheimer’s therapy. That is providing a new hook to urge action on creating a federal price ‘negotiation’ program – but not any more clarity on a viable path to enacting one.

Pricing Debate Politics

Aduhelm Approval Raises Concerns About US FDA Leadership, Senate Finance Chair Suggests

Ron Wyden points to expectations Biogen’s drug will impose a heavy cost burden on Medicare as he questions FDA’s decision to approve aducanumab. He also expresses interest in a government-sponsored technology assessment program that could help establish the value of drugs.

FDA Pricing Debate

Strength in Numbers: EU Cross-Country Drug Pricing Coalitions Join Forces

Two groups of smaller European countries have agreed to collaborate on tackling challenges relating to accessing expensive new medicines.

Europe Health Technology Assessment

From Pricing To Tax Havens: AbbVie On The Hot Seat Again With US Congress

Senate committee seeks details on company’s international tax practices as congress works to implement President Biden’s proposals on corporate tax reform.

Tax Legislation

Drug Importation: Biden Response To PhRMA Suit Highlights Infeasibility Of Trump-Era Rule

Biden administration asks court to dismiss PhRMA’s lawsuit against Trump-era pathway for drug importation from Canada because FDA has not yet cleared any Section 804 Importation Programs (SIPs). The brief outlines the high hurdles to getting a SIP approved and Canada’s opposition to the programs. It's not clear if the Biden team plans another more feasible route to drug importation.

Legal Issues Pricing Debate

340B Hospitals Could See Audits On Use Of Drug Price Savings Under Biden Administration Proposal

Legislation would be needed and will be complicated to develop. While the effectiveness of existing audits has been question by a federal government watchdog, the proposal in Biden’s budget document suggests the administration has some sympathy with drug sponsors’ position in the ongoing fight over the 340B drug discount program.

Legislation Reimbursement

Biden Budget Gives Drug Pricing Reform A Spotlight But No Specifics

Approach leaves policy development to Congress. The President understands the need to build consensus around specific policies to achieve his goals, White House Office of Management and Budget Acting Director Shalanda Young explains.

Pricing Debate Legislation

Copay Assistance Programs Threatened By Medicaid Best Price Rule – PhRMA Lawsuit

The regulatory provisions being challenged are part of a Trump-era “midnight rule” that could be changed by the Biden Administration before implementation, but PhRMA is not taking any chances about the future of copay assistance programs.

Legal Issues Regulation
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