Overview of HMSA Formulary Status Change for Lipitor
Effective April 5, 2004, the HMSA Formulary status of Lipitor 10 mg, 20 mg and 40 mg will
change to OTHER BRAND (3rd tier status) for Select and Choice plan members, who will be subject
to a higher copayment for the drug. The status will change to NON-FORMULARY for The HMSA
Plan for QUEST Members (QUEST).
The status of Lipitor 80 mg will remain PREFERRED (2nd tier) for private business plan members
and FORMULARY for QUEST members.
All Select plan and QUEST members using Lipitor 40 mg will continue to receive their 40 mg
prescriptions at a fixed copayment (2nd tier benefits) and pre-certification will not be required for
QUEST members.
Pravachol and lovastatin (generic for Mevacor) will be the PREFERRED alternatives (2nd tier for
Pravachol and 1st tier for lovastatin) for Select and Choice plan members, and will have
FORMULARY status for QUEST members.
Lescol, Altocor, Zocor, and Mevacor will remain 3rd tier medications.
Goal
Lovastatin and Pravachol are safe, well-tolerated statins that are proven to reduce cardiovascular
morbidity and mortality. Lovastatin provides a cost-efficient means for patients to attain the LDL
cholesterol goals established by the National Cholesterol Education Program (NCEP Adult
Treatment Panel III).
The change in formulary status for Lipitor is intended to maximize use of lovastatin and
Pravachol when they meet patients’ clinical needs. Patients currently on Lipitor will be
encouraged to consult with their physicians to determine whether conversion to either lovastatin
or Pravachol is appropriate for them. Physicians are also encouraged to initiate patients who are
beginning statin therapy on lovastatin or Pravachol.
Clinical Rationale
The HMSA Pharmacy & Therapeutics (P&T) Advisory Committee, composed of practicing
physicians and pharmacists, reviewed the statins in 2003 to determine the most cost-effective
agent(s) to represent this therapeutic class. The following is a summary of issues discussed:
Reduction of LDL-C
LDL reduction appears to be a class effect, with statins differing in potency. LDL reduction
guidelines and recommendations are included in the NCEP-ATP III guidelines.
Lipitor may be the most appropriate initial therapy for a small percentage of patients who require
more than a 50 percent LDL reduction to meet their goal. Thus, Lipitor 80 mg is maintained as
nd
PREFERRED (2 tier).
PM04-001b
Reduction of Cardiovascular Morbidity and Mortality
Outcomes data was reviewed to ensure the agent(s) selected best represented an evidence-based
decision. Lovastatin and Pravachol were compelling choices, as they are associated with several
trials with significant outcomes for both primary and secondary prevention.
The literature available at the time of review suggests there may be differences among the agents
regarding pleiotropic effects, such as endothelial function, inflammation, coagulation and plaque
stability. However, the association between these parameters and outcomes remains unclear.
Safety
Major side effects of statins include myopathy and increased liver enzymes (dose dependent).
When used with appropriate caution in certain high-risk patients, incidences of myopathy and
elevated liver enzymes should be reduced.
There were concerns by the P&T committee that patients treated with statins are generally on
multiple drug regimens. Pravachol has the most favorable profile in this area and may be the drug
of choice for patients who are on chronic treatment with a CYP-450 3A4 inhibitor who require
statin therapy. Some 3A4 inhibitors include cyclosporine, HIB protease inhibitors, nefazodone,
amiodarone, azole antifungals and macrolide antibiotics.
Requests for Additional Benefit Coverage/Pre-certification
Lipitor may be necessary for some patients who fail to achieve their LDL goals on therapeutic
doses of lovastatin or Pravachol. For these situations, a Request for Additional Benefit Coverage
form may be submitted for Select plan members for consideration of copayment reduction for
Lipitor. Pre-certification is available for QUEST members who may also require Lipitor therapy
under similar circumstances. The average turnaround time for these requests to be processed is
two to three days.
Drug Cost Management
Across the nation, employers, members, physicians and health plans have been challenged by the
increasing use and escalating cost of prescription drugs, and Hawaii is no exception. In 2003,
HMSA’s drug benefits expenditures totaled $280 million, and the projected increase for 2004 is
16 to 18 percent. Drug costs account for 22 percent of HMSA’s total healthcare expenditures,
fast approaching the physician reimbursement level of 32 percent. Factors that continue to drive
up these drug costs include new technology, an aging population and more aggressive diagnosis
and treatment standards for medical conditions.
HMSA has embraced the concept that appropriate drug therapy is an integral part in managing
patient care in the outpatient setting. This results in the best outcomes for our members and
reduces the overall cost of care. The cost of medications for members with limited or no drug
coverage often hinders access to care and restricts treatment options for physicians. Thus, HMSA
is committed to working closely with physicians, members and employers to maintain a highquality, affordable pharmacy benefit program and to help ensure members have access to the
medications they need. We believe the appropriate use of cost-effective medications, as
supported by practice guidelines, quality programs and formulary decisions, is our best defense
against benefit reductions.
In 2002, there were 60,536 members on statin drugs. The cost in 2002 for this therapeutic class
was $35 million, with an annual increase of 20%. This represents 12% of the total drug budget,
making statins the number-one therapeutic class for drug expenditures.
Responses to practitioners’ Lipitor conversion concerns
Lovastatin and Pravachol do not work as effectively as Lipitor.
An analysis of Lipitor utilization showed that more than 90 percent of members on Lipitor were
on 10 mg and 20 mg doses. For these members, generic lovastatin or Pravachol are clearly
supported by evidence-based trials, offer comparable LDL reductions, and therefore should serve
as appropriate alternatives for the majority of patients.
What about my patients on Lipitor 80 mg?
Currently, 2 percent of members using Lipitor are on the 80 mg dose. It is assumed that these
members require a higher-percentage LDL reduction. Therefore, Lipitor 80 mg will be
maintained at PREFERRED status for private business plans and FORMULARY status for QUEST
members. Crestor may be a potential alternative for patients who require a high-potency agent.
However, due to safety concerns based on pre-marketing studies for Crestor, the P&T committee
recommended a delay of at least six months post-release before considering review of this drug to
allow for evaluation of post-marketing efficacy and safety issues.
What about my patients on Lipitor 40 mg?
Less than 8 percent of members on Lipitor are on the 40 mg dose. Patients currently on Lipitor 40
mg would not be expected to convert to lovastatin or Pravachol. Thus, all Select Plan and
QUEST members on Lipitor 40 mg on the effective date of the formulary status change will
continue to receive their 40 mg prescriptions at a fixed copayment, and QUEST members will not
require pre-certification.
----We hope that this overview has provided you with a better understanding of the rationale for this
change in the HMSA formulary. Please be assured that HMSA is sensitive to the impact of
formulary changes on providers and members. Our goal is to ensure that, whenever possible,
reliable, consistently applied methods of analysis are used when assigning a formulary drug
status.
However, as drug costs continue to rise, it becomes increasingly challenging for HMSA to
continue providing high-quality drug-plan benefits that are affordable. Therefore, changes to the
formulary will continue to be made to incorporate new drugs that offer significant advantages in
efficacy and/or safety, and to promote the most cost-effective drugs.
If you have questions or comments, please contact a Provider Teleservice Representative at 9486330 on Oahu or 1 (800) 790-4672 from the Neighbor Islands for private business plans, or 9486321 on Oahu and 1 (800) 771-0677 from the Neighbor Islands for The HMSA Plan for QUEST
Members. For clinical questions, an HMSA staff pharmacist or physician will return your call.
COUPON
HMSA’s Generic Drug Program
For HMSA members only
Your copayment:
0.00
$
Expires 6/30/04
Redeem this coupon for
Lovastatin, a generic
cholesterol medication.
Generic drugs are high quality, safe, effective and
approved by the Food and Drug Administration.
A one-time offer from HMSA for new prescriptions only. Present this
coupon and your prescription at an HMSA participating retail pharmacy at
time of purchase. Coupon cannot be submitted directly to HMSA for cash
or redemption. Redeemable one time only. This coupon is non-transferable.
Not applicable for members of 65C Plus, 50 Plus, or QUEST.
To The Pharmacist:
•
Pharmacies will need to submit a copay condition code, using
NCPDP Field 146 for PAC Code.
•
Enter PAC Code 0002200 to waive member’s initial copay.
Copay waiver is only applicable for Lovastatin.
•
Valid for up to a 30-day supply.
•
Member will be required to pay copay if the same drug has been
received in the past 120 days.
If you have any questions, please call a Provider Teleservices representative
at 948-6330 on Oahu, or 1 (800) 790-4672 from the Neighbor Islands.
For questions specifically related to ARGUS, please call 1 (800) KC-ARGUS
(522-7487). You may duplicate this coupon for your records if desired.
(00) 1300-017 12.03 EY