Pinnacle Medicare Services – A well intended but poor decision

Pinnacle Medicare Services is the carrier for the states of Arkansas, New Mexico, Oklahoma, Eastern Missouri, Rhode Island, and Louisiana.

The Medicare carrier decides whether a given treatment will be paid for by Medicare. Pinnacle decided that AMD patients must meet the following criteria before treatment with Avastin will be reimbursed:

1. The selected patient must have failed to improve or stabilize using other currently accepted ophthalmic therapies. This therapy may include Visudyne and/or Macugen.
2. Given that the use of bevacizumab should only be attempted after other treatment failure(s), at least two fluorescein angiograms and OCT's should be performed, the first to evaluate the lesion type, location and size and the presence of subretinal fluid and the second or subsequent to document failure of the initial therapy(ies).

I don’t agree with their decision or their premise that bevacizumab should be used only after the failure of other treatments. They demand that the patient first be treated with Visudyne or Macugen. The results with Lucentis, which is derived from Avastin, are superior to Visudyne or Macugen. The early reports of the results of Avastin support that it’s better too and essentially the entire retinal community is switching to Avastin.

Visudyne is given every three months but the neovascularization can grow and a patient’s vision can decrease a lot in three months if the Visudyne is not effective. Macugen often shows a response only after four or more injections given at monthly intervals. So with either treatment there will be a delay before the ophthalmologist can give what he or she believes is the more effective treatment.

The second criterion discussing “lesion type” is probably based on the findings that Visudyne doesn’t work as well for occult neovascularization as it does for classic neovascularization. Macugen, Lucentis, and Avastin work for both types. Pinnacle wants a second fluorescein angiogram to document that the patient is getting worse. You really don’t need a second angiogram because the OCT, the vision, and the patient can tell you how they’re doing.

The main problem though is the delay in getting the Avastin. Wet AMD often progresses rapidly and once vision is lost, it usually doesn’t fully return. Larger neovascular membranes almost always mean worse vision. More scarring or bleeding means more loss of vision. That is why we tell patients over and over again to check their Amsler grids daily and to call us right away if they see any change. A day or two usually makes little difference but three months can determine whether a patient is able to read and drive a car.

I’m sure that Pinnacle has no ulterior motive. After all, Avastin is cheaper than Visudyne or Macugen. Pinnacles worries that Avastin is not approved by the FDA for the treatment of AMD. They worry that Avastin has some very nasty side-effects when it’s given intravenously to cancer patients in 800 times the dose that is used in the eye. So far we think these side-effects are extremely rare when it’s given intravitreally in AMD patients and maybe not be any different than in older patients who were not treated. We know though that Avastin. Lucentis, and Macugen get into the systemic circulation albeit in tiny amounts. We have no convincing evidence at this point that this tiny amount has deleterious effects.

This may all be moot if the FDA approves Lucentis in the next few weeks but maybe, for now, Pinnacle should rethink their decision.

References

1. Pinnacle’s Decision is at http://www.momedicare.com/provider/viewarticle.aspx?articleid=3264.
   
2. Spaide RF, et al. Intravitreal bevacizumab for choroidal neovascularization secondary to age-related macular degeneration. [ARVO 2006 poster 2962]. Available from http://tinyurl.com/gbqsp, program number 2962.
   
3. Pieramici D, et al. Bevacizumab (Avastin) in the treatment of neovascular age-related macular degeneration. [ARVO 2006 poster 3540]. Available from http://tinyurl.com/gbqsp, program number 3540.
   
4. Prabakaran SL, et al. Visual acuity response of patients with neovascular age-related macular degeneration treated with intraocular bevicazumab [sic] (Avastin) [ARVO 2006 poster 5224/B640]. Available from http://tinyurl.com/gbqsp, program number 5225.
   
5. Brooks HL, et al. Safety and efficacy of intravitreal Avastin for neovascular age related macular degeneration. [ARVO 2006 poster 5212/B627]. Available from http://tinyurl.com/gbqsp, program number 5212.
   
6. Shah AR, DelPriore LV. Comparing efficacy of AMD treatments using Lineweaver-Burke plots: A meta analysis. [ARVO 2006 poster 2190/B769]. Available from http://tinyurl.com/gbqsp, program number 2190.