|
CONSIDERATIONS FOR PAYERS
MEDICAL AND PHARMACY COST MANAGEMENT OF THE PATIENT WITH HEMOPHILIA
AND
UTILIZATION OF FEDERALLY-FUNDED HEMOPHILIA TREATMENT CENTERS
David R. Linney
The author wished to give special
acknowledgement to Amy Shapiro, M.D., Medical Director of the Indiana Hemophilia
and Thrombosis Center for her very helpful commentary in the preparation of
this article.
Hemophilia is a rare, inherited bleeding
disorder, affecting approximately 18,000 persons, primarily males, in the United
States. The most common forms of hemophilia are Hemophilia A, or Factor VIII
deficiency, and Hemophilia B or Factor IX deficiency. Each of these is
subdivided based upon the level of the clotting factor activity into three
severities, specifically – mild (levels > 5%), moderate (levels >
1% to < 5%)and severe (levels <1%). (Reference CDC website) Each
classification of hemophilia and severity requires specific care and
treatment.
Initial diagnosis and ongoing medical
management requires specialized medical evaluation and laboratory testing
(including coagulation and inhibitor studies). Complications of hemophilia
include musculoskeletal abnormalities, development of inhibitors (an antibody
directed against the deficient coagulation factor that subsequently interferes
with the effectiveness of replacement therapy), blood-born transmitted diseases,
and other problems related to the consequences of bleeding that may occur
spontaneously, as a consequence of injury or trauma, or related to a surgical or
dental intervention.
Medical treatment for hemophilia not
complicated by inhibitors consists of treatment with coagulation factor
replacement therapies generally referred to as “factor products”. In addition,
other drugs are also utilized for specific deficiencies or in certain
circumstances such as Stimate, injectable DDAVP, Amicar, etc. Medical treatment
for hemophilia complicated by inhibitors often consists of the use of repeated
doses of the deficient factor to induce a tolerant state, higher doses of the
deficient factor to treat bleeding when the inhibitor is able to be overwhelmed,
or use of inhibitor bypassing agents for treatment of bleeding episodes when use
of the usual coagulation factor replacement therapy is deemed impossible or
contraindictated.
Cost almost always increases with the
severity of diagnosis. Over 90% of the costs of hemophilia care are for factor
VIII and IX factor products. Annual costs for factor products for a patient
with severe hemophilia can range from $50,000 for a child to over $1,000,000 for
some patients on immune tolerance inhibitor treatment or through the use of
bypassing products. Costs for most “severe” patients without inhibitors
typically exceed $150,000 per year.
There are two issues for payers:
·
How does a payer assure that a
policyholder gets the very specialized medical care necessary to manage
his(/her) hemophilia?
·
How does a payer provide the
extraordinarily expensive factor products (and other specialty drugs) in
a cost effective manner?
HEMOPHILIA MEDICAL CARE COST MANAGEMENT
Care Provided by Hemophilia Treatment Centers
Hemophilia care is a subspecialty of
hematology. The federal government
recognizes that the best hemophilia care is provided by the 142 federally funded
hemophilia treatment centers (HTCs) nationally. Per CDC data, hemophilia
patients who receive their care outside of an HTC have a 60% higher mortality
rate than patients that receive their care at an HTC.
(Soucie reference) Not only does the federal government recognize the
superiority of HTCs, but so do almost all practicing hematolgists in the
catchment area of an HTC, as most hematologists readily refer their hemophilia
patients to HTCs.
HTCs provide state of the art comprehensive
care for patients with hemophilia and related bleeding disorders, working in
collaboration with other specialists
(orthopedists, hepatologists and immunologists) and primary care physicians.
HTC hematologists have specialized training in the care of hemophilia and
related bleeding disorders. Many HTCs
are in academic health centers or hospitals. Some states have more than one
HTC and only two states (Wyoming and Montana) have no HTC.
The benefits of utilizing HTCs include not
just superior care but also great potential cost savings. Savings come from the
expertise of HTCs providing the correct, specialized prescription of factor
products to treat each individual patient. Incorrect prescriptions and
inappropriate prescription dosing can result in treatment complications,
over-treatment and under-treatment as well as added expense. Delays in treatment
can also result in the need for additional treatment and greater expense.
The ability of HTCs to provide optimal, cost
effective
treatment is reinforced by extensive education
and training that HTC staff provide to patients/families about: hemophilia,
how a bleed should be treated; and, how to self-infuse at home (i.e.
hemophilia home care). HTCs also evaluate and monitor patients through
regularly scheduled clinic evaluations and are readily available to answer
patient questions about care or bleeding episodes.
HTCs train the patient or family member to
infuse (the patient) at home. Hemophilia home care is universally recognized
as the standard of care for virtually all patients for whom such care is deemed
appropriate. Home care provides the method for quickest administration of the
critical factor product and also provides great cost savings, as hospital based
treatment is avoided.
Coverage of HTC s by Payers
Because of the positive benefits of utilizing
HTCs, payers may want to refer policyholders to HTCs. If an HTC hospital or
affiliated physician group is not in-network, then a payer may want to consider
approving care at the HTC as an in-network benefit to the policyholder or
specifically approving services at an in-network rate to encourage policyholders
to go to HTCs.
Aetna is one payer that has recognized the
value and benefit of having its policyholders utilize HTCs. Aetna approves
referral of all of its hemophilia patients to HTCs and provides the highest
level of coverage afforded by each policyholder’s benefit plan to further
encourage utilization of HTCs.
Listing of HTCs
A national listing of HTCs and HTC staff
contacts can be found at this website (Website will need to be developed)
FACTOR VIII AND IX FACTOR PRODUCT COST MANAGEMENT
Providing the very expensive Factor VIII and
IX factor products in a cost effective manner is a challenge. Factor products
are priced per unit of AHF (anti-hemophilic factor). Price for each of the
different brands of factor products will vary by product and vendor. Products
for treatment of bleeding events in patients with inhibitors, or bypassing
products, are quite expensive and as hemostasis may be difficult to achieve,
often lead to the patients with the highest cost.
Payer Coverage of Factor Products
Factor products can be covered as a medical
benefit through a health plan or as a pharmacy or a specialty pharmacy
benefit through a drug plan. Health plans may or may not have in-network
vendors of factor products. Drug plans may or may not have an in-house
specialty pharmacy or an affiliate specialty pharmacy that provides biotech
injectable drugs like the hemophilia factor products. Oftentimes the health
plan in-network vendor is the same entity as the drug plan specialty pharmacy
(e.g. Pharmacy Benefit Manager [PBM] specialty pharmacy).
Payer Reimbursement of Factor Products
Payer reimbursement is typically based on a
discounted price off of Average Wholesale Price (AWP). Of note, however, in
2005, Medicare Part B established a new reimbursement methodology for Factor
VIII and factor IX factor products, based on average sales price plus 6% plus an
add-on 14 cent per unit administrative service cost. In 2006, the
administrative services cost was increased to 15 cents.
Note that actual coverage of factor
products under Medicare Part B is only 80% of this approved reimbursement rate;
so patients must either pay the remaining 20% of uncovered approved costs or
have a supplemental or secondary plan in place. This 20% payment is unrealistic
for individual patient payment responsibility.
Payer Contracting: Pricing
and Service Considerations
Different prices charged by different vendors
for the same factor product can add up to significant dollars.
For example,
for an adolescent with severe Hemophilia A without an inhibitor treated with
every other day prophylactic therapy of a recombinant factor VIII factor
product (there are 5 specific products
presently on the market) with a prescribed dosage of 1,500 units per treatment;
a payer could save considerable dollars using Vendor #2 versus Vendor #1:
1,500 units X 182 days = 273,000 units/yr
Vendor #1 Price: $1.15/unit X 273,000 units = $313,950
Vendor #2 Price: $1.00/unit X 273,000 units = $273,000
ANNUAL COST SAVINGS UTILIZING VENDOR #2 VERSUS VENDOR #1
= $ 40,950
Payers should be concerned about price and
contracting with pharmacies/specialty pharmacies or other vendors of factor
products in order to provide the prescribed product at the most economical
rate.
Best price consideration should also involve
the ability of a vendor to fill a prescription very close to the prescription
dosing. The better able a vendor is able to do this, the lower the vendor’s
submitted charge will be to the payer.
Vials of factor product come in different
sizes, based on assays of each lot that is manufactured. Vials typically come
in 3 general sizes: “250” units, “500” units and “1,000” units. Of note, one
manufacturer also has a “1,500” unit size vial and two manufacturers also have a
“2,000” unit size vial. Manufactured lots rarely assay out at exactly 250, 500
or 1,000 units. More commonly assayed lots will have somewhat arbitrary unit
numbers such as these: 232, 490, 615, 888, 994, 1246, etc. For prescription
doses that cannot be filled with a single vial, more than one vial is utilized
to meet the prescribed dose. The greater the ability of a vendor to access a
large inventory of factor products, the greater the ability a vendor has to fill
an order close to the required dose without going significantly over.
Additional units over the prescribed dose add to the overall cost of each
patient’s prescription.
For example,
using the same adolescent with severe Hemophilia A without an inhibitor who is
on an every other day prophylactic treatment dose of 1500 units of a
recombinant factor VIII product, a payer could
save considerable dollars for just a one month order
using Vendor #2 versus Vendor #1 when the
price per unit for Vendor #2 and Vendor #1 is the same, but Vendor #2 has
greater ability to fill an order closer to the prescribed dosage:
Vendor #1 1702 units X 15 treatments = 25,530 units X $1.15/unit = $29,360
Vendor #2 1510 units X 15 treatments = 22,650 units X $1.15/unit = $26,048
ONE MONTH’S COST SAVINGS UTILIZING VENDOR #2 VERSUS VENDOR #1 = $3,312
When considering contracting and best price,
it is important to consider the key service component as well. Service includes
having: access to a good inventory of factor products with long outdates; a
skilled inventory management component; necessary infusion supplies; Sharps
containers; the ability to express deliver; and knowledgeable pharmacy customer
service staff. Without good service, a patient’s care can be critically
compromised.
The importance of express delivery cannot be
emphasized enough because there will be times when a home care patient will need
an order of factor product delivered the next day to treat an emergency bleeding
episode. Overnight next day delivery in such instances is critical. If a
vendor does not have such capability, then a key service component is lacking.
Consideration of HTCs with Factor Product Programs
Payers may want to consider HTCs that have
factor product programs as a vendor option because of their ability to provide
cost savings through lower factor product pricing. Approximately half of the
142 HTCs have factor programs. Because HTCs are federally funded, they are
eligible to participate in the purchase of drugs through the Veterans Health
Care Act (VHCA) and can acquire these expensive factor products at a discount.
The VHCA drug discount program is often referred to as 340B pricing or the 340B
program (based on the VHCA statute reference).
While there is no federal requirement as to
allowable markup on factor product pricing by participating HTC factor product
vendors, HTC factor product vendors most often provide significantly lower
pricing to payers compared to other vendors.
The other advantage of using an HTC 340B
program is the unique ability to perform disease management through pharmacy
case management that only HTCs can provide. As the 340B pharmacy is an integral
part of the HTC, the pharmacy has immediate ready access to the medical
expertise of the physicians and nurses of the HTC staff. In addition, when time
is of the essence in getting a new factor product order processed stat, HTCs can
often process orders more quickly than other pharmacies because of staff on site
and the ability in many instances to deliver immediately within their catchment
area.
How to Use an HTC Factor Product Vendor
The key for payers, is to know how to be able
to use an HTC factor product vendor. HTC factor product programs only provide
discounted 340B factor product pricing to those patients they serve. (i.e. 340B
programs cannot serve patients nationally.) Therefore, payers need to develop
a separate contract, agreement or individual authorization with each HTC.
Payers should consider this option, as cost savings are often well worth the
extra effort.
Aetna, United Healthcare, Blue Cross plans
and CIGNA are payers that have made agreements with individual treatment centers
or authorized individual patients to receive factor products through 340B
programs. Aetna approves its policyholders using 340B programs as an option in
addition to its own specialty pharmacy program established in 2005, so long as
Aetna first approves the HTC cost of the product being supplied.
Listing of HTC Factor Product
Vendor Programs
A listing of HTCs that have 340B factor
product programs can be assessed at (List website which will need to be
developed).
|
