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New hepatitis C drugs offer an expensive cure

August 16, 2015

daklinza

A new generation of powerful anti-hepatitis C drugs, such as Daklinza and Sovaldi, are offering relatively quick, safe and painless cures to even the most difficult forms of hep C infection but at the cost of nearly $1000-a-dose!

Sovaldi has only been on the market for two years and Daklinza for one but both represent such a remarkable advance over existing treatment methods that governments around the world have been forced to weigh the social and medical benefits of approving and/or covering these new drugs against their staggering cost.

The British government, for one, reportedly finds Daklinza wanting and may deny this seemingly safer and faster cure for hepatitis C, genotype 3, to thousands of its citizens because it’s not “cost effective”.

But otherwise, most developed countries have so far come down in favour of approving one or both of these drugs, including Japan, all the countries of the European Union, the United States, and soon Canada.

Jumping on the Daklinza bandwagon

A year ago, in August of 2014, the European Union approved Daklinza (the Bristol-Myers Squibb (BMS) trade name of the drug daclatasvir) for use in treating adults with chronic hepatitis C, genotypes 1, 2, 3 and 4. That was a month after Japan had approved Daklinza in combination with Sunvepra (the BMS trade name for asunaprevir) for the treatment of genotype 1 hepatitis C (the most common form of the virus) in patients who either can’t handle interferon or have failed with other treatments.

Just last month, U.S. regulators approved Daklinza for use in combination with Sovaldi (the Gilead Sciences trade name for sofobuvir) against the very hard-to-treat genotype 3 hepatitis C.

In Canada, Daklinza is at step five of the six-step approval process and Sovaldi has already won approval.

And for the last three weeks, British Columbia’s PhrmaCare program has been soliciting public input on the subject of covering the cost of Daklinza treatment.

They work hard for their money

Both Sovaldi and Daklinza work to inhibit replication of the hepatitis C virus, thus allowing the body’s immune system to remove the virus to undetectable levels.

  • Both drugs are taken orally, in tablet form — no painful injections
  • They have far fewer side effects than drugs like interferon or ribavirin.
  • They offer a two to four-fold decrease in therapy length.
  • Together they can cure genotype 3 hepatitis C in 12 weeks!
  • And they both cost nearly $1000 a pill!

The U.S. FDA, in its approval last month of Daklinza for use with Sovaldi to treat hepatitis C genotype 3 infections, declared that Daklinza was the first drug that had demonstrated safety and efficacy to treat genotype 3  infections without the need for interferon or ribavirin (or their serious side effects).

The course of treatment approved by the FDA was 0ne 60mg tablet of Daklinza with one 400mg tablet of Sovaldi, once daily for 12 weeks.

In a press release, Bristol-Myers Squibb, the maker of Daklinza, pointed out one of the key benefits of the FDA approval for patients:

“The U.S. approval of Daklinza means that chronic HCV genotype 3 patients may now complete treatment in just 12 weeks with an all-oral, once-daily regimen”.

This cure is worse than the disease, if you’re a UK bean counter

The benefits of these new hepatitis C drugs come at a tremendous cost.

The list price for Daklinza is reportedly $82,467 (USD$63,000) for the 12-week regimen. Assuming that represents 84 tablets, the cost works out to $981.75 per tablet!

Consideration of this cost is surely what’s behind the advice given to the National Health Service of England (NHS) to approve Daklinza for use against all strains of hepatitis C except hepatitis C genome type 3.

This despite the fact Daklinza has been shown to be very effective against genotype 3 and that around 45 percent of the UK’s estimated 215,000 hepatitis C sufferers have the genotype 3 strain — described as being the most treatment-resistant and most aggressive type of hepatitis C; progressing faster towards liver damage, such as fibrosis,cirrhosis and hepatocellular carcinoma (liver cancer).

The advice was issued in recent “draft guidance” from the UK “healthcare watchdog”, the National Institute for Health and Care Excellence (Nice), on the grounds that prescribing the drug for genotype 3 hepatitis C patients was not cost-effective, according to the Guardian,

On the surface, approving Daklinza against genotype 3 hepatitis C would appear to put the NHS on the hook for hundreds of millions of pounds — over 146 million pounds perhaps, given that Nice estimates that there are at least 3000 chronic Hepatitis C sufferers who would benefit from the approval.

On the one hand there’s the aforementioned cost of the drug — the Guardian pegged it at $99734.22 (£48,700 — and on the other hand, the cost of filling a NHS-approved drug prescription, which appears to be capped at a maximum flat rate of CAD$16.79 (£8.20). And a UK citizen can save more money the more prescriptions they take by buying prescription prepayment certificates (PPC).

It’s the Government that has to pick up the millions of Pounds-worth of difference between the cost of the prescription and the actual cost of the drug.

One has to hope that Nice’s opposition is not solely based on the up front cost of Daklinza — that they’ve responsibly factored in the costs of not quickly curing genotype 3 Hepatitis C: the palliative care, the liver transplants, the cancer treatment and the cost to society of losing citizens to an untimely death.

Surely a similar evaluation will be taking place in all the provincial capitals of Canada — Medicare being provincially administered.

Hopefully we’re British in name only

Here in British Columbia, Daklinza is being considered for possible coverage under the BC PharmaCare program, which is open to all B.C. residents and which helps defray the cost of most prescription drugs in the province.

We’re in the final week of a four-week public input stage of the process (July 22 to August 19) where BC PharmaCare has invited all affected parties to express their opinion about covering Daklinza.

B.C. PharmaCare’s Your Voice page says that input is requested from all B.C. residents who can answer yes to any of the following questions:

  1. Do you have the medical condition for which the drug would be used?
  2. Are you a caregiver to someone who has that medical condition?
  3. Does your patient group represent patients who have that medical condition AND have you registered with PharmaCare to give input?  (Learn more about registering your organization).

Daklinza has been shown to cure chronic hepatitis C infection in the majority of patients, according to B.C. PharmaCare.

Used in concert with other anti-Hep-C drugs, it blocks the replication of the hepatitis C virus (HCV) and allows the body’s immune system to remove the virus from the blood and effect a virologic cure, meaning that HCV is cleared from the patient’s blood and remains undetectable three months after the Daklinza treatment has ended.

Where are all the generics?

Public healthcare systems such as Canada’s Medicare or England’s NHS, love cheap generic versions of expensive brand name prescription medications, if they can get them legally.

And where public healthcare systems can’t or won’t cover these new drugs, chronic hepatitis C sufferers will now simply take their chances and buy generic versions over the Internet, where possible.

Already in March, there were reports of a $10 generic version of Gilead Sciences’ $1000-a-pill Sovaldi being manufactured in Bangladesh and likewise generic daclatasvir is being sold out of China.

4 Comments
    • That is interesting: a safe, inexpensive, over-the-counter antihistamine, chlorcyclizine (CCZ), may be an effective hepatitis C inhibitor in its own right — across all genotypes. And the study is associated with the U.S. National Institute of Healrh (NIH). Thank you for bring it to my attention.

  1. Was it approved??

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