Vice President and General Counsel
Lantheus Medical Imaging, Inc. (“Lantheus”) appreciates the opportunity to submit comments to the Centers for Medicare and Medicaid Services (“CMS”) regarding the National Coverage Analysis for Positron Emission Tomography (CAG-00065R2). We fully support CMS enabling expanded coverage for reasonable and necessary Positron Emission Tomography (“PET”) services with PET agents that demonstrate clinical value in light of all the scientific data and other controls associated with FDA approval. This updating of the PET coverage policy should be accomplished by CMS removing the blanket exclusion of coverage for new PET agents.
Lantheus is the developer and manufacturer of a number of radiopharmaceuticals used for nuclear cardiology and nuclear medicine procedures, including Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) for myocardial perfusion imaging (“MPI”), Thallium 201 (Thallous Chloride Tl201 Injection) also for MPI, and TechneLite® (Technetium Tc99m Generator).
Lantheus is a member of the Medical Imaging and Technology Alliance ( “MITA”), and has participated in that group’s work on the request for reconsideration of the PET National Coverage Determination (“NCD”). Lantheus is also a member of the Council on Radionuclides and Radiopharmaceuticals (“CORAR”).
Lantheus is currently conducting a Phase 3, multi-center clinical study with a new positron emitting agent, flurpiridaz F 18, to assess myocardial perfusion by PET imaging in patients with known or suspected coronary artery disease (“CAD”). These clinical studies include Medicare patients and document the clinical efficacy of PET for Medicare patients.
Lantheus comments on the proposed rule for PET coverage are outlined below:
1. Lantheus strongly supports the MITA proposal, which would eliminate the exclusionary policy for new PET radiopharmaceuticals and indications. The denial of coverage for novel PET agents when these are approved by the FDA for uses consistent with current Medicare coverage for PET, limits provider choice of the agent he or she believes is most appropriate for an individual patient, and without reimbursement effectively denies Medicare beneficiaries access to the range of PET agents that have been demonstrated, by substantial evidence, to be safe and effective for their intended uses.
Lantheus does not believe it necessary or appropriate to require a local coverage review of all new FDA-approved PET imaging drugs by the Medicare Administrative Contractors (“MACs”). This would be an extraordinary, labor intensive process as each contractor across the US would perform parallel coverage analyses. Moreover, although the evidence base supporting coverage would be identical in each jurisdiction, there is a risk that some MACs might support coverage and others might not. How would physicians explain to their beneficiaries that they cannot have access to an FDA-approved imaging drug simply because they live in the “wrong state.”
If the exclusionary policy is removed CMS would still have the ability to restrict or withdraw coverage if it determines that based on clinical experience there is not sufficient evidence to fully validate the benefits for Medicare patients of a specific use of a particular agent. CMS still has the option to implement a National Coverage Determination to withdraw or restrict coverage on an agent by use basis if it believes it is necessary to do so.
2. Lantheus strongly believes that since (i) FDA approval of new PET radiopharmaceuticals requires carefully controlled clinical trials which demonstrate appropriate safety and efficacy by meaningful statistical methodology and (ii) an increased rigor of manufacturing has been implemented with new cGMP requirements, it is now appropriate for CMS to eliminate the exclusionary language in the NCD.
3. Lantheus notes that the current NCD, which automatically excludes from coverage any novel PET radiopharmaceutical, is not consistent with CMS policy for lower energy SPECT radiopharmaceuticals nor with CMS policy for any other drugs or biologicals approved by the FDA under an NDA or BLA. Long-established Medicare policy provides coverage for novel drugs and biologicals approved by the FDA when used for their labeled indications. Although CMS and its local contractors may consider whether coverage is appropriate for uses outside of labeling, CMS has very rarely questioned coverage for the FDA-approved indications, and we are not aware of any other example where CMS has actually denied coverage for an FDA-labeled indication for a drug or biological. CMS has not articulated any rationale for singling out PET imaging drugs.
4. We recognize that F18 FDG, an early PET imaging drug, did not go through the traditional requirements for FDA approval involving adequate and well-controlled clinical trials. Because of this limitation in the evidence base to support coverage for F18 FDG, Medicare coverage of this agent was delayed for several years until the findings from the National Oncologic PET Registry (“NOPR”) were evaluated. By contrast, new PET imaging drugs are required to have substantial evidence of safety and efficacy comprising adequate and well-controlled trials in order to obtain FDA approval.
5. For example, as noted above, Lantheus is currently conducting a Phase 3 clinical study on flurpiridaz F 18, a PET radiopharmaceutical. The protocol for this study was reviewed by the FDA prior to patient enrollment. Lantheus has obtained two separate special protocol assessments from the FDA in connection with this study which will consist of two carefully controlled multicenter clinical trials enrolling a total of approximately 1,350 patients. This follows a comprehensive Phase 1 and Phase 2 clinical development program which generated substantial safety and preliminary efficacy information. A summary of this clinical experience was presented to CMS during a meeting with Lantheus in April 2011.
Title - A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (“PET”) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (“CAD”)
Primary Outcome Measures:
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography.
Secondary Outcome Measures:
Diagnostic performance evaluation of CAD PET compared to SPECT.
Diagnostic performance evaluation of multivessel disease PET compared to SPECT.
Detection of CAD in subgroups: pharmacologic stress, females and BMI>/=30.
Image quality of rest and stress PET compared to SPECT.
Diagnostic certainty evaluation of rest and stress PET compared to SPECT .
Evaluation of reversible defect size of rest and stress PET compared to SPECT.
Safety evaluation of flurpiridaz F 18.
6. There has been recent development and acceptance of professional society practice guidelines and Appropriate Use Criteria (“AUC”) for imaging. For example, the American Society of Nuclear Cardiology and the American College of Cardiology have developed evidence-based Appropriate Use Criteria for myocardial perfusion imaging intended to promote appropriate utilization of these procedures and to minimize unnecessary testing. This is a significant development to help ensure the right patient gets the right scan at the right time.
7. The prevalence of Medicare beneficiaries is high among those who are candidates for myocardial perfusion imaging for the diagnosis of CAD. It is not in their best interest to be denied or delayed access to these important imaging drugs that have received rigorous evaluation and FDA approval.
Lantheus congratulates CMS for its decision to open the PET National Coverage Analysis. This is an encouraging step toward the assurance that Medicare beneficiaries will have access to important, clinically-proven PET imaging drugs in procedures which already are covered by Medicare that can provide clinically meaningful information to their physicians and ensure that they receive appropriate care.
If you have any questions please contact Randy VanCoughnett at email@example.com or 978-436-7995.
Michael P. Duffy
Vice President and General Counsel
Lantheus Medical Imaging
331 Treble Cove Road
North Billerica, MA 01862