How TPP helps pharma Presented by the Partnership for America's Health Care Future

BEYOND BIOLOGICS: PHARMA DOESN'T COME UP EMPTY IN TPP — Market protection for the expensive class of biologic medicines has been the drug industry’s focus with the Trans-Pacific Partnership trade deal. They didn’t win the 12 years of market exclusivity companies get in the U.S., but that doesn’t mean they didn’t get some valuable economic benefits in the deal which was finally made public late last week. And that’s not counting the 5-8 years of biologic protection in several TPP countries that used to have less or none.

To tick off a few IP wins: The 12 TPP countries must extend patent terms to drugs to compensate for delays in the drug approval process. Small molecule drugs and combination drugs that include at least one new chemical entity are entitled to five years of marketing exclusivity. Conduct a new clinical trial to get an additional use — that’s three more years of exclusivity. Plus countries will need to establish a framework similar to the U.S. Hatch-Waxman Act so that branded companies will be given notice and have the opportunity to seek judicial review or other redress when a generic company tries to copy their product. One industry representative who’s been focused on trade said companies are pleased by the “strong patent language” in the final deal. The additional intellectual property and marketing protections “are not insignificant,” he added.


… The transparency section of TPP will also force government bodies that make national coverage and reimbursement decisions to provide the drug and medical device industries with more information about those decisions as well as formal opportunities to provide comment and to appeal, a longstanding industry aim. Some TPP countries “are very opaque,” on pricing determinations, a pharma company rep noted.

… The biologic situation is still a sticking point, not only for industry but for key members of Congress. Senate Finance Committee Chairman Orrin Hatch said Friday that TPP is too weak on IP protections particularly for biologics and said the White House may need to renegotiate. The Obama administration has formally notified Congress of the president's intention to sign the deal.

Happy Monday and welcome back to Prescription PULSE, where we remember that this week in 1666, Samuel Pepys documented the first blood transfusion. The dog-to-dog transfusion took place in Britain and came about four decades after English physician William Harvey declared that blood circulated throughout the body with the heart acting as the pump, Wired notes. http://bit.ly/1Mp1Xzh

HELP STILL STUCK ON ‘INNOVATIONS’ BILL — No sign of a breakthrough last week on the big remaining obstacle to the release of a bipartisan draft of the Senate’s medical innovation bill: mandatory funding for NIH and FDA. Committee staffers are working on how to include billions in new funding in a way that satisfies Chairman Lamar Alexander’s insistence that any extra money be targeted to specific needs, according to lobbyists following the halting effort. Democrats led by ranking member Patty Murray continue to insist on new funding — the House's 21st Century Cures bill provided $8.75 billion to NIH and $550 million to FDA. Time is very tight. The draft would need to circulate for feedback ahead of a markup by year’s end — Alexander’s goal. The likelihood that the Innovations for Healthier Americans bill slips into 2016 grows with each passing week. Lobbyists say further delay would be a significant obstacle to it becoming law in an election year.

CALIFF GET’S A DATE: NOMINATION HEARING SET — HELP plans to consider Robert Califf’s nomination for commissioner of FDA on Nov. 17. Califf is thought to have broad support in the committee and the Senate, although Sen. Bernie Sanders and some consumer advocates have opposed Califf, citing his ties with the drug industry. The HELP committee will vote on the nomination at an executive session that hasn't been scheduled yet, the committee said. How soon he could get a full vote in the Senate is uncertain. Nebraska freshman Sen. Ben Sasse has pledged to put a hold on all HHS nominees until the agency responds to questions about Obamacare’s CO-OPs — more than half of which have collapsed. Califf would replace Acting Commissioner Stephen Ostroff, who has been in the position since Margaret Hamburg stepped down last spring.

… The National Health Council last week offered the latest endorsement for Califf from a major health group. “Dr. Califf has developed a proven track record of working with patients and other stakeholders to improve the lives of people with chronic diseases and disabilities,” NHC CEO Marc Boutin wrote to HELP leadership, urging Califf’s swift confirmation. http://bit.ly/1Q9ezNg

HHS TAKES ON DRUG PRICES IN NOVEMBER FORUM — An invite-only meeting at HHS headquarters Nov. 20 will address rising spending on drugs. There has been no shortage of such events in D.C. recently, but this is the first one underwritten by the White House. Value-based and outcomes-based purchasing strategies for drugs are on the agenda, as well as other new purchasing and utilization approaches that Medicare and Medicaid could use. The meeting will also look at the current and future drug classes that contribute to rising health care costs and will discuss the challenges patients and physicians face in accessing medicines. Pharmaceutical industry representatives, patient advocates, health care providers, employers and payers will attend, but HHS has not yet named names. One person who will be there : Memorial Sloan Kettering’s Peter Bach, known for his new tool that helps determine the value of cancer drugs. Industry insiders expect some hints of what the Obama administration might attempt — with or without Congress — on drug prices. For more information see: http://1.usa.gov/1kpltRa

CLINTON TEAM MEETS INSURERS — Top Hillary Clinton staffers hosted insurance executives at the campaign's Brooklyn headquarters last week, coming face-to-face with an industry that Clinton ranked among her top "enemies" during the first Democratic debate — alongside drug companies, the NRA, Iran and Republicans. Clinton's senior policy adviser Ann O'Leary met with Marilyn Tavenner, the chief executive of AHIP and former CMS administrator. Executives from the BCBSA met with Clinton's staff Thursday.

— A campaign aide said the talks focused on health plan consolidation, which Clinton has raised on the trail. AHIP, which requested a meeting, said the broad conversation also covered Obamacare exchanges, mental health, delivery system reform and, notably, high drug costs. The campaign wouldn't comment on whether it would take meetings with drug companies, in the spotlight over prices. While Clinton has proposed insurance reforms that payers don't like, it's pushing far more sweeping policies to tackle drug costs. Details in Brett and Rachana Pradhan's story here.

** A message from the Generic Pharmaceutical Association: Generic drugs are a long-term solution to rising health care costs. These safe and more affordable medicines generated $254 billion in savings in 2014, according to the annual Generic Drug Savings in the U.S. report. These savings are critical for patients, providers, taxpayers, and others. Learn more: http://www.gphaonline.org/ **

PHARMA IN THE STATES: OPIOID ABUSE PROMPTS SPECIAL SESSION IN NH — New Hampshire Gov. Maggie Hassan summoned the legislature back to work on comprehensive substance abuse legislation. In the call to a special session starting Nov. 18, Hassan said the “heroin and opioid crisis is the most pressing public health and safety challenge facing our state, and we must act quickly to give patients, providers, parents and law enforcement better tools to combat the epidemic.” On Wednesday, the state’s Board of Medicine voted to adopt emergency rules for the prescribing of opioids. That includes requiring a detailed informed consent form. The special session announcement: http://1.usa.gov/1SlWpGp

SENATE LAUNCHES BIPARTISAN DRUG PRICE INVESTIGATION — ICYMI, the Senate Special Committee on Aging launched a bipartisan investigation into price hikes on old, off-patent drugs. Committee leaders Sens. Susan Collins and Claire McCaskill targeted four companies with document requests, including Valeant, whose stock continued to plummet on the news. The move came as House Democrats announced a new Affordable Drug Pricing Task Force meant to pressure Republicans to join investigations by the lower chamber, including the minorities on the Oversight and Ways and Means committees. The Aging committee plans a hearing in December: http://prn.to/1SxgM3w

CMS CONCERNED ABOUT MEDICAID ACCESS TO HEP C DRUGS — The agency is worried about Medicaid programs rejecting costly new hepatitis C treatments, officials wrote to all 50 states last week. CMS also wrote to four drug companies, Abbvie, Gilead, Johnson & Johnson and Merck, asking whether they are offering Medicaid the lowest available price for the drugs as required by law. CMS said Medicaid programs might be imposing conditions for coverage that unreasonably restrict access to the treatments, pointing to some programs barring healthier patients from receiving the new drugs. The CMS letter acknowledges states' concerns that the drugs will bust their budgets, but noted that competing products are helping to drive down drug costs. More from Sarah here.

… A recent study found that Medicaid is denying nearly half of hepatitis C drug requests, compared to just under 10 percent for commercial payers and under 5 percent for Medicare patients.

PITTS TO RETIRE — Rep. Joe Pitts, who has chaired the Energy and Commerce health subcommittee since 2011, announced Friday that he won't seek reelection in 2016. The Pennsylvania Republican will retire after 10 terms. Rep. Brett Guthrie is next in seniority, but Prescription PULSE hears that Rep. Michael Burgess, a doctor and avid health policy wonk, is very interested. No decision on a successor is likely anytime soon, as Pitts’ term won't be up until the end of next year.

— Chairman Fred Upton's statement: "As Chairman of the Health Subcommittee, Joe Pitts has been a legislative workhorse - from 21st Century Cures, finally fixing SGR, to dozens of public health laws, he's had his fingerprints on more bills than most folks in Congress."

HHS OIG TO INVESTIGATE NEW DRUG, DEVICE ISSUES IN FY 2016: The Office of Inspector General’s newly released FY 2016 work plan includes new oversight of pharmacy reimbursement for brand drugs under Medicare Part D. Prices for the most commonly used brand name drugs have risen substantially since 2002, the work plan notes. For example, prices increased nearly 13 percent in 2013, a rate that was eight times greater than the general inflation rate. On the drug pricing front OIG will also be looking at specialty drug pricing and reimbursement in Medicaid. Other new studies include a look at Medicare payments for implanted medical devices, a review of whether Medicare Part D beneficiaries are being prescribed inappropriate drug combinations, and examination of CMS’s ability to oversee Part D pharmacies.

… The 2016 work plan also includes a revised study to shine some light on the industry's relationship with docs. OIG will examine the number and nature of financial interests reported to the CMS Open Payments Program, a sunshine database of doctor payments from drug and device makers. It also will look at how well CMS is ensuring compliance with Open Payments reporting. The full work plan: http://1.usa.gov/1KU1Eqv

OIG HIGHLIGHTS KICKBACK FOCUS FOR PATIENT ASSISTANCE — Two letters sent to charities that operate patient assistance programs in late October were made public last week, and they highlight HHS’s focus on making sure these programs don't violate anti-kickback laws. OIG told the charities that aspects of their programs, which help patients with medication costs, would need to be modified. For example, OIG said the charities cannot maintain any disease fund that provides copayment assistance for only one drug or only the drugs made or marketed by one company or its affiliates. Nor can the charity limit its assistance to high-cost or specialty drugs. The letters: http://1.usa.gov/1LMtSr3 and http://1.usa.gov/1HnolTO

ICER RECRUITING CER EXPERTS — The Institute for Clinical and Economic Review is seeking nominations for experts to join two evidence review groups that are helping develop the institute’s reports evaluating the cost of new drugs. It’s recruiting for the New England Comparative Effectiveness Public Advisory Council and the California Technology Assessment Forum. Applications can be sent here: [email protected]

NPC NAMES MERCK EXEC AS CHAIRMAN — Patrick Magri, Merck’s senior vice president for managed markets and policy, will chair the board for the National Pharmaceutical Council for the coming year. His term began Friday. “As we address the changing health care environment, I know his guidance will help us to constructively address ongoing and emerging health policy challenges,” NPC President Dan Leonard said in a statement. http://bit.ly/1SwpwXC

CATCHING OUR ATTENTION: CNBC INVESTIGATES OPIOID CO. — CNBC pieces together details from criminal complaints, attorneys general reports and other sources to document allegations that Insys Therapeutics, with physicians across the country, may have fraudulently pushed its fentanyl drug on inappropriate patients. The product, Subsys, an oral spray, is one of the most potent and dangerous opioids, meant for late-stage cancer patients. But this may not have stopped the company from skirting the law to make millions. Insys CEO Michael Babich stepped down late last week, after the CNBC story ran. In response to the CNBC investigation Insys said it takes patient safety seriously and is commitment to ensuring proper prescribing of its drug. The full story: http://nbcnews.to/1Mj2YIW

** A message from the Generic Pharmaceutical Association: GPhA’s new report shows that generic drugs are lowering health costs and broadening access to medicine with $254 billion in 2014 savings and $1.68 trillion in savings over the last ten years. There are still policy and regulatory changes that could encourage greater competition in the market, lowering costs and enhancing access even more. GPhA urges Congress to help expedite FDA review of more than 3,800 generic drugs awaiting approval; curb abuses of FDA safety programs such as Risk Evaluation and Mitigation Strategies by some brand drug companies; and introduce a competitive regulatory framework for the burgeoning biosimilars industry. Learn more about the incredible contribution the generic drug industry makes to patients and the health system: http://www.gphaonline.org/ **

Follow us on Twitter Sarah Owermohle @owermohle