Thursday, October 01, 2009

MN-01 GOP Blind to NICE

In The Republican Party of Minnesota's First Congressional District blog, Bruce Kaskubar warns about Eye Care in the UK.

I don’t know if Mr. Kaskubar is an ophthalmologist and I do not think that his intention was to scare us, but instead was to express concerns about healthcare legislation – specifically a “rationing board”.

Mr. Kaskubar cites an OpEd that was printed in the Wall Street Journal concerning the National Institute for Health and Clinical Excellence (NICE) – the UK board that promotes "best practices" in medicine.

One might think that if it is printed in the WSJ, that it is current and factually correct, but be warned it can also be misleading and ill-informed.

Mr. Kaskubar accurately cites “In 2007, the board restricted access to two drugs for macular degeneration, a cause of blindness. The drug Macugen was blocked outright. The other, Lucentis, was limited to a particular category of individuals with the disease, restricting it to about one in five sufferers."

OK, blindness is scary … but shouldn’t the question be asked : Why did NICE restrict use of these drugs?

On January 2, 2007, Genentech Inc., the manufacturer of Avastin™ (bevacizumab) and Lucentis™ (ranibizumab), informed ophthalmologists that the ongoing SAILOR clinical study revealed a higher incidence of stroke in the 0.5-mg Lucentis™ dose group. When Lucentis™ was initially approved for use, the warning label expressed concerns of the theoretical risk of thromboembolic events with intravitreal inhibitors of VEgf,3 a drug class that also includes Macugen™ and Avastin™.

Ah, that poses an interesting question --- is the risk of a stroke worth preserving the patient’s vision ?

There is also the question of cost. In the US, Lucentis™ runs close to $2,000 per monthly shot (and if the coverage is through Medicare, the co-pay is $400). By contrast, Avastin™ — a close biochemical cousin to Lucentis™ — is priced for use in far larger doses as a cancer treatment, so the tiny amount needed for injections into the eye costs only about $40 a shot. Genentech makes both medicines and has been under pressure for the pricing of Lucentis™ when Avastin™ is apparently effective in treating wet age-related macular degeneration (AMD) … as it is in treating colon, lung and breast cancer.

Those two reasons would seem to be valid justification for NICE to restrict usage while it studies the drug.

In the US, the FDA is involved in the CATT Study which has the primary aim to evaluate the relative safety and efficacy of treatment of subfoveal AMD with both Avastin™ and Lucentis™, determine an appropriate dosing schedule and, to see if there is any clinical difference between the two drugs.
I wonder if the FDA had issued the same ruling as NICE did, would Mr. Kaskubar or the WSJ writer complain that the motivation was due to rationing ?

Incidentally, Mr. Kaskubar and the WSJ writer failed to update the status from NICE’s 2007 instructions. NICE in August 2008 issued a report authorizing the use of Lucentis™ with the UK government paying for the first 14 injections in each eye being treated. If people need more than 14 injections per eye, the manufacturer has agreed to provide the drug at no additional cost.

The obvious question is : What is the price of Lucentis™ in the US versus what it is in the UK ?

Now, I am not an ophthalmologist … and that’s the point … the concept of a second opinion is always beneficial … and NICE seems to be contributing to that goal.

Common folks, like me, rely on the medical community to know what to do … but that may be idyllic.

Governor Tim Pawlenty has complained about direct-to-consumer prescription drug advertising resulting in increased number of patients asking physicians for treatments because they heard about it on TV or a friend told them about it. Additionally, the pharmaceutical industry pays physicians to give “educational” seminars on their products creating a potential conflict of interests. Eli Lilly was fined $1.4 billion dollars in January to settle a lawsuit by the federal government that it illegally promoted drugs while Pfizer paid $2.3 billion fine in September for the same activity. Recently, Schering-Plough offered a variety of psychiatrists around the country up to $1,600 a day and $170,000 total to talk about Saphris, a new psychiatric drug.
Clearly, costs are being impacted ... and that's where the issue should be --- not "rationing".

Let’s not be blind to misleading stories … it is a fact that “rationing” occurs today when insurance companies decide if they will cover a drug or procedure.

Let’s not promote fear.

Mr. Kaskubar is concerned about a “rationing board” but fails to acknowledge that the Obama Administration's proposal for a Council for Comparative Effectiveness Research does not have the same authority as NICE does.
IMO, that is a mistake.

Let’s enact reforms that promote “best practices”. Controlling costs and ensuring best practices can best be achieved when government is involved protecting consumers and patients.


Bruce said...

The post in question was taken from an item of interest to the Missouri Society of Eye Physicians and Surgeons (MoSEPS) though Mac leaves that detail out of his description.

The point of presenting it was due to the Obama administration's insistence that there will be no rationing with so-called ObamaCare. Whether insurance companies ration is completely beside the answer to the question of rationing in ObamaCare.

NICE is pertinent because it was formed along the same lines as the CCER, for best practices. To say that it will not have the same authority as NICE seems to me naive or disingenuous.

I have not researched the basis for the NICE limitations on these drugs but would make two observations: (1) the existence of one potentially reasonable limitation does not mean that all limitations are reasonable; (2) MoSEPS was not fond of it and they are ophthalmologists.

I completely disagree that "controlling costs and ensuring best practices can best be achieved when government is involved protecting consumers and patients" and unequivocally believe that counterexamples abound including rent, price, and production controls throughout the ages.

At one point Mac stated that, "folks like me rely on the medical community to know what to do" and at the same time he wants the government making best practices decisions. To me, those are two different things.

I prefer a quick-acting medical community of well informed health care professionals to a slogging bureaucracy of a relatively small number of political appointees.

The point is that ObamaCare will include limitations on care imposed from outside the patient/physician relationship in spite of our president's contrary insistence.

Holly Cairns said...

Let’s not promote fear.

Also, I wonder how we can address cost while continuing to fund research. Drug companies are for-profit and they factor into our overall health care reform discussion. How do we entice companies to make good drugs for cheap? Research and develop new cures? Etc.

Yes, and thank goodness for consumer protection. Back in the 1900's they used to put tapeworms in diet pills, for example. Get thin, and then die.