�Թϲ�����

A watchdog group has asked ethics officials at the Department of Health and Human Services to investigate the relationship between Alex Azar, who heads the department, and Eli Lilly, his former employer, over a recently proposed rule that would benefit drug makers. The request by the Campaign for Accountability, a nonprofit, comes in response to a proposal the Trump administration is considering to reduce or restrict rebates, which are essentially a type of discount that drug makers provide pharmacy benefit managers off the wholesale, or list, price for their medicines in order to receive favorable placement on formularies, which are lists of insured drugs. (Silverman, 8/28)

Gilead Sciences Inc.’s CAR-T blood cancer drug Yescarta is too expensive to be recommended for use in the U.K.’s state-funded health service, a national regulator said Tuesday, casting doubt on whether other European countries will grant approval for the cutting-edge class of drugs. The move comes a day after Gilead’s Yescarta and competitor Novartis AG’s Kymriah received approval from the European Commission, paving the way for the drugmakers to seek approval from each member state in Europe. (Mancini and Martuscelli, 8/28)

A new organization dedicated to eradicating high drug prices in the Netherlands has found what it believes is its first example — and will ask the government to investigate. At issue is a medicine known as CDCA that is used to treat people with cerebrotendinous xanthomatosis, or CTX, a rare genetic metabolic disease. An earlier version had been available for decades at a low cost, but was purchased by a company that later took the drug off the market. Last year, however, the company was granted marketing exclusivity by regulators and, at the re-launch, boosted the price many times over. (Silverman, 8/27)

Last week the U.S. Senate gave consumers – along with doctors, hospitals, and Connecticut’s health insurers — a win by approving bipartisan legislation that would require this “direct-to-consumer” advertising to include the price of these medications, which are among the costliest on the market. The Senate-approved measure would provide the Department of Health and Human Services with $1 million to implement proposed Trump administration rules that would require the disclosure by drug makers. (Radelat, 8/28)

The United States and Mexico’s new trade deal quickly drew criticism from consumer and generic drug groups that said a 10-year biologic patent protection would hurt affordability and the biosimilar industry. The two-way deal, announced Monday by President Donald Trump, would set patent protections for biologic drugs at 10 years. (Owermohle, 8/28)

Pfizer Inc.’s pipeline may finally be delivering. A new study shows that patients with a rare condition that can lead to heart failure lowered their risk of dying by 30 percent after being treated with Pfizer’s tafamidis. The finding could give the biggest U.S. drugmaker another potential blockbuster medicine and challenge a biotech startup marketing its own groundbreaking treatment for the same disease. (Hopkins and Lipschultz, 8/27)

Four Colorado prisoners who sued prison chief Rick Raemisch in Denver U.S. District Court, claiming they were not adequately treated for hepatitis C, have reached a $41 million settlement with Colorado that ensures all infected inmates will be treated for the deadly disease. According to the settlement, the Colorado Department of Corrections will spend $20.5 million during this fiscal year for hepatitis C care and $20.5 million next year, according to a letter from John Spring, one of four plaintiffs in the class-action lawsuit filed in 2017 by the American Civil Liberties Union. (Mitchell, 8/28)

Late last week, the U.S. Senate passed an amendment to the spending bill that would require pharma companies to disclose the prices of any products they advertise directly to consumers. The package devotes $1 million in funding to implement the new requirement, which co-sponsoring Senator Chuck Grassley (R-Iowa) believes will be vital for bringing “transparency to drug pricing and educating the public about the cost of their prescriptions,” he said in a statement. (Weintraub, 8/28)

A spending bill passed by the Senate last week includes $1 million for the Trump administration to craft new regulations that would force pharmaceutical companies to include prices in prescription drug advertisements. But there are plenty of questions about how such regulations would work and whether the Department of Health and Human Services has the legal authority to make drug companies disclose prices in TV, radio and other ads to consumers. (McIntire and Siddons, 8/27)

Cigna’s acquisition of Express Scripts sweeps the last major standalone PBM off the market at the same time as CVS’s deal for Aetna blurs the line between health plans and drug benefits. That assumes the mergers are finalized, as widely expected. Cigna shareholders are expected to approve its merger this Friday. The deals would reshape both Medicare Part D and Medicare Advantage — but most of the uncertainty about the future of rebates focuses on Part D, the prescription drug benefit. (Owemohle, 8/22)

European and U.S. pharmaceutical associations have waded into a diplomatic row between Germany and Saudi Arabia, warning that ongoing restrictions on German-made drugs could hurt Saudi patients and dampen future investment in the kingdom. In a strongly worded letter to Crown Prince Mohammed bin Salman, a copy of which has been seen by Reuters, the associations highlighted the level of concern in Germany and elsewhere about restrictive procurement measures implemented by Riyadh in response to criticism of its policies. (Barkin, 8/22)

Sales representatives of Pfizer Inc., the world’s largest pharmaceutical company, will join Exact Sciences Corp.’s sales representatives in selling the company’s non-invasive screening test for colorectal cancer to physicians and health systems under an agreement announced Wednesday. Pfizer will make at least 625,000 sales calls a year for Exact Sciences under the agreement. (Boulton, 8/22)