Posts Tagged ‘Prescription Drug Costs’

PBM Consulting – New AWP Benchmark

Friday, August 20th, 2010

Here we are approaching the one-year anniversary (September 26, 2010) of the effective date of the McKesson AWP settlement, and unfortunately, little has changed.  At WBC (wbcbaltimore.com) we have followed this case from the get-go, through negotiation and settlement. We have helped our clients with their direct participation in the class action settlement, as well as active involvement in evaluating their PBM.   The question remains: where’s the new pricing standard that was anticipated?

As a refresher, part of the settlement involved the publishing of AWP by First DataBank, who along with McKesson Corp., were defendants in the action.  One of the remedies was for First DataBank to cease publication of this standard within 2 years of the effective date of the settlement.  Many thought a new benchmark would be introduced in short order to replace the perceived gap in a reliable and representative alternative.  Much was written about whether WAC, AMP or ASP would fill the void.  Several PBMs altered their benchmark and have adopted WAC in their pricing proposals.  So what happens? The vast majority of PBMs simply adjusted their pricing discounts to reflect a lower AWP.  They tauted it as “cost-neutral” to the client.  What they didn’t say was the adjustment. i.e. reduction in cost,  did not save the client any money.  They did, however, remind  clients that they weren’t going to be charged more!

To further delay the wheels of change, Wolters Kluwer, the publisher of Medispan, which is the largest competitor to First DataBank’s AWP’s Blue Book, has announced that they will continue to publish AWP “until relevant industry or governmental organizations develop a viable, generally accepted alternative.”  Interestingly, Medispan was a party in the settlement and had agreed to stop publishing by September 26, 2011.  Let’s see if Judge Saris, the judge who heard the case and approved the settlement, has anything to say.

There really is no national standard that has gained traction as a suitable alternative. A committee that was commissioned by the National Council for Prescription Drug Programs recommended that WAC be used as a replacement benchmark for single-source drugs, while no recommendation was made to cover multi-source products.  In our opinion, the best bet for future guidance seems to reside with our friends at CMS. They prefer AMP, and plan to begin publishing AMP pricing in October. We believe that if and when this occurs, the rest of the industry will fall into line within a year. It is a big “if” however, since the retail pharmacy associations don’t seem to want any part of more transparent pricing, at least as it applies to their pharmacy setting. When CMS announced a recent plan to produce pricing surveys and publish results with acquisition cost pricing, they were faced with a firestorm of resistance from the pharmacy lobbies.  Litigation has been promised if CMS continues to pursue this course, so we’ll have to wait and see what happens.  It may be a harbinger of things to come related to PBM pricing benchmarks.  Stay tuned!

Pharmacy Benefit and Healthcare Reform – “It’s Alive”

Saturday, March 6th, 2010

“Officials announced today that passing the Senate’s version of healthcare reform will end heart disease, cure cancer and increase every family of four’s net worth by $1 million dollars over the next ten years.”  And so it seems as one unbelievable claim after another is trumpeted as justification to launch this monstrous piece of legislation onto the American public. Frankenstein MonsterAnd like the Frankenstein Monster (huge, ugly, but really just misunderstood) this healthcare ”thing” will be very difficult to kill once it has been given life.

Loyal readers may be wondering how pharmacy benefits will be impacted by this tale from the crypt (wait, is that Frankie or Harry Reid?). Here’s how:

Pharmacies will begin to restrict access by refusing to accept Medicaid payments. Walgreen’s announced today that they will no longer be accepting new Medicaid patients in Washington state after April 16th. 2011367936_walgreens18m.html Expect others to jump on board, both in other jurisdictions as well as other chains. With millions of newly eligible Medicaid beneficiaries, this will prove problematic, not just for getting scripts filled, but as a barometer of access problems in the physician provider community as well.

Employer plan sponsors will also begin to drop coverage as soon as they find out that the cost of continuing their programs far exceeds the penalty they will have to pay by opting out. Medical benefits as well as Rx plans, will be transferred to the The Insurance Exchanges that will be established to offer subsidized individual coverage for non-corporate plan participants, and who will ultimately drive private insurers from the arena.

What remains to be seen are the issues related to formalizing a program of pharmaceutical re-importation, allowing the Secretary of Health and Human Services the ability to negotiate prescription drug prices with pharmaceutical companies, or authorizing a regulatory pathway that will lead to FDA approval of generic biologicals.

What’s known is we will wind up with far less competition, reduced access, higher costs and a staggering, unsustainable new unfunded entitlement program!

The Okra Effect – Reducing Pharmacy Benefit Costs

Monday, February 8th, 2010

Diabetes as a consequence of American lifestyles continues to rage in epidemic proportions. According to statistics from the American Diabetes Association (www.diabetes.org), 23.8 million people have diabetes (10.7% of the population over Age 20 and an additional 57 million people who are in a pre-diabetes stage). If current trends continue, 1 out of 3 children born in the year 2000 will develop diabetes by 2050! Throw in the complications of diabetes including heart disease, kidney disease, high blood pressure, nervous system disease, stroke and blindness and the total healthcare costs are staggering.

This healthcare crisis has not gone unnoticed by some influential folks. Of course, one of the biggest namestemp in “cause awareness” is Oprah. It was recently announced that she is helping raise diabetes awareness by promoting free blood glucose screenings at Walgreen’s (Free-Blood-Glucose-Screening-at-Walgreens).

Hopefully people will hear the message and respond. Many in the media refer to it as “The Oprah Effect” and the need is huge. There are 5.7 million that have diabetes and have not yet been diagnosed.

While this is a great effort and getting folks in to be tested will save lives, it may not have much of an immediate effect on reducing pharmacy benefit costs.  In fact, short-term costs will escalate while potentially reducing  the overall costs of healthcare over a more mid-term period.

In addition to screening, we would like to see Americans get serious about their dietary and exercise habits in order to turn the tide on this deadly trend. We’re thinking of it as “The Okra Effect”,Okra one which incorporates fresh fruits and vegetables as a bigger component of our menu. The fact is that okra (as just one example) is great for you, and  that the mucilage and fiber in okra helps adjust blood sugar by regulating its absorption in the small intestine.

So this should be an easy recipe: more fruits and vegetables; mix in a heaping portion of moderate exercise (like walking); yields better glucose control with reduced dependency on manufactured pharmaceutical products; and equals less pharmacy benefit spend!

Controlling Drug Costs – Pharma Good Guys

Saturday, October 17th, 2009

Healthcare reform debates in Washington are fascinating spectator sports. In order to advance one’s agenda, the best strategy seems to be to find someone to demonize. imageIt goes something like this: create a crisis fervor, point the finger of blame at some straw dog, and try and steer public opinion for doing something!

No group has caught the heat over the years more than the pharmaceutical industry. “Big Pharma” is an easy target. Everyone complains about the high cost of healthcare and more pointedly, the high cost of prescription drugs. We then hear a background chorus chime in about “excessive profits.”  They fail to mention the number of high paying jobs, research grant funding and philanthropic donations.

We sometimes hear from  industry spokespeople  regarding the cost of R&D and the price of innovation.  What we don’t hear enough about is the value that many therapeutic regimens represents, both in terms of reducing overall healthcare expense (better chronic disease control) and quality of life. In fact, extending life itself to many patients.

Certainly there is room for improvement in the way the pharma industry manages certain business practices. For example, it’s hard to justify extending patent protection and creating different indications for older drugs.  And let’s not neglect to mention the folly of a  drug company that introduces a new, much more expensive drug that has no evidence of improved patient outcome.

But where the drug industry really falls short, is the lack of self promotion when it comes to assisting needy patients. Pharma supports over 270 Prescription Assistance Programs (“PAPs”)  and Co-Pay Foundations representing approximately 450 different programs. These are the programs that coordinate assistance for those patients that cannot afford their medications and are funded to a large extent by pharma. The phama industry donates multiple millions of dollars in free drugs annually as well as over $300 million in cash annually to help insured patients meet their co-pay requirements.

Patients in need (including Seniors with Med D coverage) can contact a third-party agency for help or go directly to the pharmaceutical manufacturer of the drugs they need. In the vast majority of cases, pharma comes through for these patients.

Three cheers for pharma on this count!

AWP Settlement – Who Pays?

Friday, October 2nd, 2009

As most pharmacy benefit plan sponsors know, the new change in AWP became effective on September 26, 2009. On that date and in response to the associated court settlement, First DataBank and Medi-Span adjusted the AWP mark-up over the wholesale acquisition cost (“WAC”) to no more than 20%. This represents an approximate 4% reduction in AWP for 1,440 NDCs included in the settlement and an additional 21,500 NDCs that are being voluntarily included. Many imagePBMs have proffered adjustments to their contracts with plan sponsors to address this situation.  The underlying question, however, is “Who pays?”

The Plan sponsor should be expecting to hear good news. “Guess what, your costs for providing prescription drugs have gone down.” But in the PBM world, this is not what happens. There are several approaches  that the PBMs are using to respond, with no universal answer. The vast majority of PBMs have presented an alternative that they claim is “cost-neutral” and maintains the “original economic intent” of the contract for PBM services. This means that none of the parties in the PBM contract are expected to change their relative economic positions that were in effect prior to September 26th.

Most of the PBMs have asked their plan sponsor clients to accept a reduction in the contractual discounts designated in their current PBM contract. An AWP-15% discount will become AWP-12.75% under the new pricing arrangement. While this approach may create equity when compared to pre-September 26th pricing, is that really the fair approach? And more importantly, should it be “sold” to the sponsor as a “no one pays more” solution.

Here’s an example: old AWP is $100 with a 15% discount = $85. Now, the new AWP will be $96. This should be good news to the sponsor. But the PBMs know that if they honor the 15% discount, one of two things happens: one, the PBM has to eat the reduction in their profit margin because they are obligated to pay the pharmacies in their retail network a contracted price; or two, the pharmacy has to accept reduced margin for their transaction.

From the view of the pharmacy, when AWP for our example drug was $100 with a 15% discount, the pharmacy was paid $85. If their cost is $80, they received the $5 spread plus a dispensing fee of say, $2.00, so their total earned was $7 on this Rx.

Now, the new AWP will be $96 and the plan sponsor’s 15% discount creates a cost to the sponsor of $81.60, not $85. The pharmacy would see their spread on the script reduced to $1.60 ($81.60 minus $80 cost). The $2.00 dispensing fee is added to the  $1.60 for a total earned of $3.60. This cuts their “profit” almost in half! Who pays?

Well, the answer under this “cost neutral” approach is the plan sponsor. Back to our example: In order to keep the pharmacy and the PBM whole, the PBM asks the sponsor to reduce the contracted discounts. The $100 AWP that becomes $96 now has a discount of 12.75% in order to create a “cost-neutral” invoice of $85, the same as pre-September 26th. The PBM doesn’t have to subsidize the pharmacy and the pharmacy doesn’t have to cut their margins.

While it’s true that this approach won’t require the sponsor to pay more than they are currently paying, they are not paying less. Some would argue that paying less is the objectivewhen hiring a PBM to manage pharmacy costs.

That being said, is this solution acceptable? It depends on the view of the sponsor. The threat from not accepting this option is a potential loss of pharmacies in your network. Most PBMs have protected themselves by included language in their contract for services with the plan sponsor that reserves the right to alter pricing in the event of this AWP change. The plan sponsor may decide to find a PBM that is more aligned with the sponsor’s interest. The PBMs, of course, prefer to present it as a “painless” adjustment, in an attempt to not alienate their clients. You must keep in mind, however, that someone always pays!

AWP Settlement – Should Change Everything

Sunday, September 27th, 2009

Finally, September 26th has come and gone, the effective date of the new AWP settlement changes. Your PBM is still processing claims.  Members are still having their drug cards honored at the image pharmacy counter and if you are a drug benefit plan sponsor, you’ll be receiving adjusted invoices to reflect this momentous event.  The problem is that for most plan sponsors, all this “normalcy” is a bad thing!

The adjustments that many had hoped would happen as a result of the settlement, have been altered in a way that creates no economic improvement for the pharmacy benefit plan sponsor! The AWP settlement involved a roll-back of the AWP benchmark pricing for 1,400 drugs that had been artificially inflated. If you were a plan sponsor that relied on an AWP benchmark provided by First DataBank or Medi-span, then you were entitled to file an application to be part of the class action settlement fund. One would think that an adjustment to pricing that lowered the cost of drugs should be  benefiting  the folks who pay for those drugs, i.e., the plan sponsors and their members.  However, most PBMs have included language in their contracts that enables them to make an adjustment in their pricing, so that the “original economic intent” of the contract is maintained.

Most of these same PBMs have sent letters to their clients asking them to sign amendments acknowledging these changes. The requested change is usually in one of two forms: either a reduction in contractual discounts; or a decision by the PBM to maintain their own AWP benchmark that keeps the same markup to wholesale acquisition cost (“WAC”) thereby re-creating the same AWP that was in effect prior to September 26th!

Rather than just let this practice slide as a”business as usual” routine, WBC thinks it should be a great watershed event in the evolution of pharmacy benefit management. When pricing improvements such as this one occurs, a plan sponsor should use the moment to re-qualify their PBM. Is the PBM committed to a mission of serving the exclusive benefit of the plan and their members, or do they have an overriding imperative to serve their own shareholders?

Adjustments to maintain the “economic intent” are designed to maintain the PBMs net margins and  comes at the expense of the plan.  We believe that this pricing event creates the perfect environment to challenge the validity of the whole “AWP Discount” model.  It should be compared to true acquisition cost pricing as a form of direct contracting, an approach that refines the role of a PBM and enables the plan sponsor to dramatically reduce the cost of prescription drugs to the plan and their members.

PBM Consulting – Biosimilars – Same but Different

Sunday, July 19th, 2009

Lot’s of talk this week about biosimilar legislation as a means of reducing the cost of prescription drugs.  It’s actually been an ongoing topic for many years in biotech circles and PBM consulting (www.wbcbaltimore.com).  The current expense of biologic drug therapies and the expected growth into chronic disease states for conditions with much higher prevalence makes it major concern for those who are responsible for paying the tab.

The debate focuses on the need to provide patent protection for brand name biologics vs. the desire to offer patients and payors a lower-cost, ‘generic”-type alternative. Manufacturers cost of R&D must be adequately recaptured in order to insure a continued pipeline of innovative therapies. Payors complain about the huge expense. A single patient using a single biologic drug therapy may cost $400,000 annually. Fortunately, patients using biologics represent less than 1% of the population, yet it can eat up 20% of the drug spend.  That number is projected to grow and to reach 45% of drug spending by 2030.

Of course, there are no real generic alternative available, due to the biologic nature of the drugs. imageUnlike chemical compounding that occurs in regular pharmacy (small-molecule drugs), biologics are created at the cellular level within proteins. Traditional pharmacy uses drugs that address symptoms of disease, and generics must be identical or bio equivalent to their brand name counterpart. Biologics try and fix the actual disease and cannot be replicated exactly.Biosimilars then, are drugs that are “sufficiently similar”to products already approved by the FDA. In fact, some have suggested that we not even call them biosimilar (the term used in Europe) as a descriptor, but prefer “follow-on protein.”

The FDA needs to define a pathway for biosimilars to be approved for use. Several issues that need to be addressed are:

1. Definition of what exactly will be considered a biosimilar;

2. Define what is a “reference product” and how many years of patent protection or exclusivity will be granted (proposed ranges have been 3-14 years. Senate proposal is 12 years);

3. Must include all biologics, current and those in development, including gene therapies and cancer vaccines;

4. Decide whether to use comparability clinical trials or rely on FDA discretion

5. Other issues include labeling, substitution and intellectual property rights.

Pharma has come out in support of biosimilar approval, as long as there remains an adequate period of exclusivity. 12 years appears to be the minimum they will accept. Lobbying efforts will continue to be extremely fierce!