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Showing posts with label drug pricing. Show all posts
Showing posts with label drug pricing. Show all posts

House and Senate At Odds On Drug Pricing Legislation

P&T Journal - for the original article go HERE.

Neither bill will pass as is but there’s room for compromise.

Momentum in Congress to pass legislation aimed at slowing down prescription drug price increases seems to have slowed as Democrats and Republicans are at loggerheads over competing solutions. However, given the heated criticism of pricing by drug manufacturer from both parties, Congress is likely to do something, perhaps passing legislation forcing companies to provide transparency on costs of drug development and other pricing factors. Key committees in both houses of Congress have passed separate bills.

The Democratic House bill is called the Lower Drug Costs Now Act (H.R. 3). It passed three separate House committees with nary a Republican “yea.” It was expected to be approved by the House sometime before the end of 2019 and, again, probably along party lines. It won’t pass the Senate as is. The Senate bill, which was approve by the Senate Finance Committee, is called the Prescription Drug Pricing Reduction Act (S. 2543). The legislation represents the bipartisan work of the Republican chairman, Sen. Chuck Grassley of Iowan, and ranking Democrat, Sen. Ron Wyden of Oregon. The bill, which has not come to the Senate floor as P&T went to press, passed the committee by a vote of 19-9. Every Democrat voted for the bill, but most of the Republicans, with the exception of Grassley and a few others, voted against it.

Both the House and Senate bills have many provisions aimed at lowering drug prices for seniors, and, in some cases, all consumers. The bills would also reduce costs for the Medicare and Medicaid programs. But the key provisions in each attempt to limit drug price increases and introductory prices, but they do so in very different ways. That divergence is the main reason neither bill will pass Congress as is.

Republican support of the Senate bill is doubtful because many in the party see the provision in the bill that forces down manufacturers’ prices as federal price controls, a characterization that Grassley and Wyden refute. The provision they are arguing about would require prescription drug and biological manufacturers to pay a rebate to Medicare equal to the difference their price hikes for Medicare Part B or D drugs or biologicals and the inflation rate, as measured by the Consumer Price Index for All Urban Consumers (CPI-U).

Adding to the bill’s political tribulations is a threat by Wyden to withdraw Democratic support unless a vote is held on the Senate floor on cementing insurance protections for people with pre-existing conditions.

In the House, the partisan divide is clear and thorough: Democrats are solidly behind the bill and the Republicans just as solidly against it. The legislation, which was put together with strong input from House Speaker Nancy Pelosi, would allow the Health and Human Services secretary to directly negotiate prices of drugs that are determined to contribute the most to Medicare drug costs and are without generic competitors. As written, the legislation says that a minimum of 25 drugs can be on that list and a maximum of 250 drugs. Drug manufacturers who opt out of accepting the secretary’s negotiated rates would incur steep penalties, beginning at 65% of the drug manufacturer’s gross sales of the drug from the prior year. For every quarter the drug manufacturer elects not to participate, the penalty would increase by 10%, with a maximum penalty of 95% of a drug’s gross sales. Like the Senate bill, the House bill has less controversial other provisions, such as reducing out-of-pocket costs and creating discount programs for eligible Medicare beneficiaries.

The Pharmaceutical Research Manufacturers Association (PhRMA) opposes both the Senate and House bill. “If H.R. 3 becomes law, it is lights out for a lot of very small biotech companies that are pre-revenue and depend on attracting capital,” Steve Ubl, PhRMA CEO told reporters in October. A PhRMA blog criticizes the Senate bill this way: “Unfortunately, the Senate Finance Committee has pushed for changes that would upend Part D without any immediate and meaningful savings for most patients at the pharmacy counter.”

Some patient advocacy groups are concerned that the Pelosi bill will cause drug manufacturers to tap the brakes on drug development. But other groups, like AARP, support the legislation and the stated intent of reining in drug prices.

The near certainty that neither bill will pass as is doesn’t mean that there isn’t room for compromise. For example, the Senate bill has a provision that requires companies to report “documentation to justify price increases” in 2021 for drugs with price increases of 100% in the preceding 12 months or at least 150% in the preceding two years. The numbers change slightly in successive years. The House requires reporting on drug price increases of 10% in one year or 25% over three years. Compromise legislation might a middle ground between the two bills.

Stephanie Kennan, a senior vice president at McGuireWoods Consulting, a major lobbying firm who was health policy advisor to Sen. Wyden for about 10 years, says, “The House has passed bills that reflect some of the provisions in the Senate Finance Committee’s proposal. It would make sense that some form of the Senate Finance Committee’s bill becomes the base of a compromise.”

Author bio: 
Mr. Barlas is a freelance writer in Washington, D.C. who covers issues inside the Beltway.

House Democrats Push Competing Drug Price Transparency Bills

P&T Journal - for the original article go HERE.  For a PDF version go HERE.

May Provide Useful Data, But Not Downward Pressure on Prices

It was undoubtedly a coincidence that Novartis subsidiary AveXis announced “innovative access” programs on May 24, 2019, for its new drug Zolgensma (the highest-priced ever) three days after the House Energy and Commerce health subcommittee was considering new bills to rein in costs of new and existing drugs. Zolgensma (onasemnogene abeparvovecxioi) is the latest entrant in the expensive gene-therapy category; the onetime treatment for a fatal early childhood disease is projected to cost somewhere around $2 million. This price is based on the fair-price analysis that the Institute for Clinical and Economic Review carried out, and which Avexis cited in its May announcement (although they didn’t include the dollar amount). Avexis argued that Zolgensma’s one-time cost will be 50% lower than the current 10-year cost of spinal muscular atrophy (SMA) therapy.

Novartis’ agreeing to some form of value-based pricing with several health insurers is unlikely to silence criticism of the $2 million pricetag, however. What’s more likely is that Zolgensma will become a topic of congressional rhetoric as Sovaldi and Firdapse did during the May 21 hearings. Those hearings featured two competing drug price “transparency” bills, which Democrats are pushing as part of their effort to reduce high prices.

One bill––Stopping the Pharmaceutical Industry from Keeping Drugs Expensive Act, aka the “SPIKE Act” (H.R. 2069)––has already passed the House Ways and Means Committee. The Energy and Commerce health subcommittee also considered the Fair Accountability and Innovative Research Drug Pricing Act or “FAIR Drug Pricing” Act (H.R. 2296).

The two bills are similar, as both require companies to notify the Department of Health and Human Services (HHS) when the price of an existing drug increases by a certain percentage, or when a new drug is introduced whose price exceeds some threshold (SPIKE Act only). That notification must include certain information, including total expenditures on R&D, as well as revenue and profit for the applicable drug. Neither bill limits price increases.

Mark Miller, until recently the executive director of the Medicare Payment Advisory Commission, said the bills might produce some useful information, “but in and of themselves [they] won’t be enough to affect the drug price issues you’re facing now.”

Fred Isasi, Executive Director of Families USA, was particularly critical of Sovaldi and Firdapse’s makers. Gilead ended up with Sovaldi after purchasing Pharmasett, which had undertaken substantial R&D in 2011. Isasi stated that Gilead asked someone on Wall Street how it should price Sovaldi, got an answer, and then quadrupled the recommended price. Sovaldi, used to treat hepatitis C, was originally priced around $84,000.

Raymond Schinazi, who is now a professor at Emory University and Co-Director of the HIV Cure Scientific Working Group within the Emory University Center for AIDS Research, was co-founder of Pharmasett and did some of the early research on Sovaldi. Schinazi says, “Gilead bought Pharmasset for $11.4 billion but made more than $15 billion selling Sovaldi in the next 12 to 14 months after launch. Pretty impressive! I wasn’t involved in any way in the pricing, but I do feel it was somewhat excessive [as] this isn’t an orphan disease... more than 71 million people are infected globally.”
He adds, “When Gilead bought Pharmasset, the drug wasn’t perfect [because] it had to be combined with something other than interferon and/or ribavirin. There was no guarantee the drug was going to be approved. Gilead did do a lot of R&D and sponsored many clinical trials that led to Sovaldi’s approval.”

Firdapse, which is used to treat a rare neuromuscular disease, was acquired last year by Catalyst Pharmaceuticals from Jacobus Pharmaceutical. Its cost increased to $375,000 per year, after having been free through the FDA’s compassionate-use program for people who needed it. Extraordinary price hikes for long-existing generic drugs such as insulin have also been the subject of previous congressional hearings.

The consulting firm KEI submitted a paper to the health subcommittee noting that many developed countries limit annual price increases for drugs. Canada limits increases to the consumer price index increase (CPI). “It should be noted that the United States is an outlier regarding the freedom to increase prices beyond the general rate of inflation,” KEI reported.

Representative Mark Pocan (D-WI) has introduced a bill that would limit price increases. The Stop Price Gouging Act (H.R. 1093) imposes an excise tax on companies selling prescription drugs that are subject to price spikes and that exceed the annual percentage increase in the Chained CPI.
Pocan’s bill wasn’t included in the May 21 hearing, and there was no response from his spokesman as to why.

Miller informed the health subcommittee about several options for Congress to rein in high drug prices, particularly regarding Medicare Parts B and D. He has endorsed a number of initiatives that the Trump administration has either proposed or accomplished via rulemaking. However, the bills that the House subcommittee considered on May 21 touched on very few items on Miller’s list, if any.

Author bio: 
Mr. Barlas is a freelance writer in Washington, D.C. who covers issues inside the Beltway.