Hepatitis drug coverage in English-speaking countries

Today I have a few updates about drug coverage in some English-speaking countries:

  • For more than a year in Australia, the government’s Pharmeceutical Benefits Scheme has been charging low-income patients $5.30 for treatment with direct-acting antivirals. Other Austrailians pay only $37.80 for a treatment. A family physician or nurse practitioner can prescribe the drugs in consultation with a gastroenterologist or hepatologist specialized in chronic hepatitis C infection.
  • Residents of the United Kingdom await better coverage of drug costs for hepatitis C. Last year the National Health Service limited its coverage of the hep C miracle cures to 10,000 patients per year, whereas 160,000 people in the UK were infected with hepatitis C. A spokesman for the NHS said, “As prices come down we hope in future years to be able to expand treatments even further. . .”
  • Canada, where each province runs its own drug plan, has been seeing better coverage for hepatitis C antivirals. British Columbia, for example, has announced that treatment for everyone with hepatitis C, no matter their degree of liver damage, will be covered by its Fair PharmaCare plan starting in 2018. Under the plan, patients pay a deductable, depending on their income. After paying the deductible, they pay 30 percent of drug costs to a maximum amount. At that point the plan pays everything. For example, a hepatitis C patient with a family income of $50,000 a year would pay a total $1,650, including the deductible and 30 percent payment. The plan would pay everything after that.
  • In the United States, drug plans and Medicaid may not cover hep C treatment for all levels of fibrosis. The big worry there recently has been the repeal of the Affordable Care Act and the Senate’s proposed replacement, which could allow States to alter their rules so that pre-existing conditions may preclude coverage. Hepatitis C can hide in the system for decades, until it emerges as a pre-existing condition.

Blog readers, please let me know the news from your location.

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British Columbia to cover drug costs for anyone with hepatitis C

In a year or so, British Columbians waiting for hepatitis C treatment will need to wait no longer. The province recently announced that starting in 2018-19 its PharmaCare drug plan will cover direct-acting antivirals for any resident with the disease, no matter how much liver damage they’ve suffered—or not suffered.  Among the drugs PharmaCare will cover are

  • Daklinza (daclatasvir)
  • Epclusa (sofosbuvir/velpatasvir)
  • Harvoni (ledipasvir/sofosbuvir)
  • Sovaldi (sofosbuvir)
  • Sunvepra (asunaprevir)
  • Zepatier (elbasvir/grazoprevir)

Hep C often takes several decades to seriously attack the liver, and many Canadians have had to wait years before their provincial drug plan would cover these quick, incredibly effective treatments. The situation has been similar in the United States, where restrictions under Medicaid vary from state to state.

Three years ago, many plans insisted a patient be diagnosed with stage 3 fibrosis or even cirrhosis before they would cover the drugs. More recently, that dipped to stage 2 or even 1 in many provinces and in some U.S. states.

Gradually, insurers worldwide have been negotiating lower prices for bulk buying of the drugs. The pan-Canadian Pharmaceutical Alliance has been negotiating on behalf of all Canadian provinces. It’s success in lowering costs has allowed British Columbia’s announcement. Under B.C.’s PharmaCare, patients pay a just small percentage of the drug cost, depending on their income. I live in British Columbia. I’m so happy to learn this news.

 

‘The Sovaldi of rare diseases’ on the market for children

For the two years I’ve been writing this blog, I’ve stuck to stories specifically about hepatitis C. Some were critiques of the high prices charged for hep C drugs.Today I’ve learned that the $100,000 or so required to rid patients of the liver killing disease has been topped by far by a drug that can save children’s lives—if their parents can afford millions of dollars for treatment.So I’m writing about a new (not for hepatitis) drug, Spinraza.

The drug maker Biogen has just gained U.S. approval for Spinraza. Injected directly into the spine, Spinraza can halt or even reverse spinal muscular atrophy. SMA afflicts babies and children. They progressively lose muscle control and die, usually before age 20 and often as toddlers or infants. SMA is the leading cause of death in infants. Spinraza costs $750,000 U.S. per year for the first year of treatment, and $375,000 per year after that.

Biogen, like the companies that developed drugs for hepatitis C, can be applauded for its research on the breakthrough SMA drug. But like hep C drug makers, Biogen is charging far too much.

Interestingly, healthcare analyst Geoffrey Porges, called Spinraza “the Sovaldi of rare disease drugs” Porges is an analyst for Leerink, a healthcare investment bank. He made the statement to the biotech publication Endpoints News. Gilead’s Sovaldi set the pace in drug pricing in its 2014 rollout of Solvaldi. The hep C treatment cost patients $84,000 for eight weeks of pills that were combined with interferon or simeprevir. Although the cost of Solvaldi and other hep C drugs has decreased somewhat in the past two years, many, many patients still cannot afford treatment.

Now there’s a much costlier drug that can keep helpless children from dying. One can imagine the dollar signs in the eyes of Biogen shareholders—and the tears in the eyes of parents who cannot afford the drug.

Phony Harvoni spurs new packaging in Japan

Gilead Sciences in Japan has decided to change the packaging of Sovaldi and Harvoni in that country. The direct-acting antivirals will now be sold in blister packs rather than bottles, which would make it harder for counterfeiters to scam patients who have hepatitis C.

This comes soon after Japan’s  health ministry announced that phony Harvoni tablets had  been found in drugstores in Nara Prefecture. The false drugs were sold in three stores, all part of the same drug store chain. The bogus Harvoni  tablets were discovered when a patient questioned the odd shape of the pills, which were different in colour and shape from the standard orange Harvoni tablets. The bad pills had been placed in actual Harvoni bottles.

Gilead has investigated the counterfeit drugs and has announced they have not caused any health problems. But presumably there were no cures. That must have been extremely disheartening to patients who took the phony pills. It’s almost worse than not being able to afford the real ones.

World Hepatitis Day can celebrate cures for all

On July 28, World Hepatitis Day will mark a milestone for those who have rare genotypes of heptatitis C. Epclusa, Gilead’s one-pill combination of sofosbuvir and velpatasvir, has been shown to cure genotypes 1 through 6.

Previously, those with genotypes 4 – 6 could be cured only with interferon. The drug often caused extreme flu-like symptoms as well as depression for close to a year. A large portion of patients abandoned treatment before they were cured.

Twelve weeks of Epclusa alone has proven 98 percent effective for those with almost all stages of liver damage. The drug taken with ribavirin has been shown to cure 94 percent of patients who have decompensated cirrhosis.

The cost of Epclusa is $75,000 for 12 weeks. That’s less than other direct-acting antiviral treatments, except for Merck’s Zepatier , priced at $54,000. Still, that’s about the same as the median annual household income  in the U.S. ($53,657 according to the 2014 Census). That’s a big price to pay, but at least now there’s hope for everyone.

Down Under is way up on top with hep C treatment

Australia recently became the first country in the world to make direct-acting antivirals free for all of its citizens who have hep C and are at any stage of fibrosis. The government health plan pays for the drugs.

Anyone who has hepatitis C and holds a Medicare Card (every Australian citizen gets one) can be treated though their general practitioner. The process is simple. After a person tests positive for HCV, their doctor consults with a hepatologist or gastroenterologist and writes the prescription. It doesn’t matter how high—or low—the person scores on a Fibroscan.

The country’s Prescription Benefit Scheme pays for the drugs. The patient pays either a $6 or a $38 dispensing fee, depending on income.

The unfettered, virtually free DAA treatment policy was introduced in March after intense campaigning from Hepatitis Australia and other advocacy groups.Map of Australia

Ribavirin still used for hep C–often to lower the treatment cost

Despite the demise of interferon, the debilitating drug that was used for two decades to treat hepatitis C, many patients must still deal with one component of the old treatment. Under the brand names CoPegus and Rebetol, ribavirin is sometimes prescribed in addition to direct-acting antivirals. Doctors most often prescribe it for difficult cases of hep C.

The difficult cases include patients with cirrhosis. Recent studies show that ribavirin combined with DAAs can reduce the length of treatment for many of these people (see Ribavirin: Past, present and future).

Ribavirin’s common side effects include anemia, insomnia and irritability. For some patients, the side-effects can be mild. Many doctors feel they are a small price to pay in exchange for big drug prices patients can’t afford. Twelve weeks of a DAA plus ribavirin instead of 24 weeks of a DAA alone could save a patient many tens of thousands of dollars. Ideally, patients and doctors shouldn’t have to think about that. But they do.