Tags: prescription

Prescription Drug User Fee Act -- Patient Focused Drug-Development -- Docket Number FDA-2012-N-0967

Link: http://www.gpo.gov/fdsys/pkg/FR-2013-04-11/pdf/2013-08441.pdf

Last year the FDA soliciting public comments to narrow down the diseases to focus on for its Patient-Focused Drug Development Initiative, which has the goal of obtaining the patient's perspective on certain disease areas during the five period of the PDUFA (Prescription Drug User Fee Act) V. To assess a product's benefits and risks involves an analysis of the severity of the condition treated and the current treatment options available for the given disease. This information is a critical aspect of FDA's decision-making as it establishes the context in which the regulatory decisions are makde. The FDA believes that drug development and their review process could benefit from a more systematic and expansive approach by obtaining the perspective of patients on disease severity and current available options in a therapeutic area.

They had nominated 39 diseases, where narcolepsy was one of them, and were looking to narrow the list down to 20.

And, the result is Narcolepsy got selected! :cool:

Even though there were directions on how to make the comment anonymously, I choose to include my name and I had gone with greater emphasis for Narcolepsy since it was my most recent diagnosis, and since it was first brought to my attention during the after dinner conversation aboard the Nautica Queen....though we Narcoleptics tend to have more than one thing wrong...and perhaps someday I'll get to know what my current problem is called (something I've had over over 10 years now, but only started getting really bad the shortly after the conference.)

The conference was October 19-21, 2012...I got back on the 23rd, and wrote the letter on the 24th. Since I had book Wednesday to Wednesday off from work for the conference....

The resulting list for FY 2013-2015 are: Alpha-1 antitrypsin deficiency; breast cancer; chronic Chagas disease; female sexual dysfunction; fibromyalgia; heomphilia A, hemophilia B, von Willebrand disease, and other heritable bleeding disorders; HIV; idiopathic pulmonary fibrosis; irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease with persistent regurgitation symptoms on proton-pump inhibitors; lung cancer; myalgic encephalomyelitis/chronic fatigue syndrome; narcolepsy; neurological manifestations of inborn errors of metabolism; Parkinson's diseases and Huntington's disease; pulmonary arterial hypertension; and sickle cell disease.

There will be another public process to determine the list of disease areas for FY 2016-2017.

Wonder what the future meetings will be....

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I got an Eye Exam

So, since my Narcolepsy Diagnosis, I've been having vision problems...since September. I suspected that some of it was due to my medication, and I did find that I was right...but learned from Facebook before the NN Conference in October that what I was experiencing was more associated as a side effect of my stimulant than the other. I might be starting too strong with it in the morning.

Making a change on that front, brought about an almost immediate improvement....and while at the conference, I learned of another thing to adjust and that also made for a pretty quick improvement.

However, I still felt that my prescription had changed...but didn't feel like I could get an eye exam and new glasses done in time for LISA, so I put it off....except I guess I put it off too long...because I finally got the eye exam today....but, I'm off to Gallifrey One next week. Not enough time to get a new pair of glasses. Manhattan, KS needs an 1 hour place....though do they do computer progressives in an hour? No, I need my own time machine.

For the progression...see "The Result of my Latest Eye Exam"

And, then after the eye exam, the doctor remember that I had done poorly in the upper left quadrant of my left eye in the peripheral vision test, and that he would see how I did to see if there is concern.

I again did poorly in that area. Said this kind of thing usually points to Glaucoma, but my eye pressures are perfect so that doesn't. So, he's not sure still...though he did notice in the up close exam of my eyes that my left eyelid does hang longer than my right, so maybe that's impeding my ability to see in that quadrant. But, he recently got this new machine that can quickly determine if it is and he had checked my insurance and saw that I had met my deductible. (Getting my Xyrem refilled on Jan 2nd, made me meet my $2500 deductible really quickly....and it didn't hurt as much as I thought it would either...) So, the extra test would be full covered. The normal eye exam portion is covered 100% and not subject to deductible....as are other defined preventive exams....

Meanwhile, I'm wondering if a pair of prescription sunglasses will work into my plan this year? Since the change is much, and given how I bought 3 new pairs of glasses last year....and only have the one pair. I should have a spare.

Perhaps, I might revisit Transition lenses again... for one of the pairs.... :hmm: Though so far I haven't made any use against my limited use FSA, which I had considered lowering, but in the end had kept at the same level of funding this year.

But, first how will I get by at Gallifrey One.... guess we shall see... :roll:

QHDHP, HSA and Chronic conditions

This month is annual open enrollment at work....time to review plan changes and make selections for January 1st, 2012. This year, premiums have jumped up a lot...particularly for single people. The implication is that for the last few years, they had drifted from the mandate that employer pays 95/55 of the health insurance costs (95% of single, 55% of family). Guess that means they had been paying more than 95% of my cost? Because my BCBS Plan A premium jumped by 44%. Plus every 3 years they renegotiate plans...and this was the year they did that.

Other than the premium jump...which was much greater compared to previous years (which hadn't jumped up as much as I had seen with previous employers). There were only a few changes this year.

The coverage on the 3 plans (A, B, C) have all stayed the same. All plans are PPO, Plan A has a 20% co-insurance rate versus 35% co-insurance rate for Plan B (in-network, all are 50% for out-of-network)...and Plan A has higher co-payments than Plan B...and higher deductible. New next year, is that BCBS will be offering Plan C (QHDHP). Other changes, is that Coventry and PHS have now merged, and United Health Care is now the 3rd provider option (though technically there were 4 provider choices last year, with addition of UMR... a sister company of UHC, but with a smaller network...and Coventry and PHS not yet merged.)

When I first started, they were HMO, PPO, QHDHP plans....and I had gone with PPO, even though all my providers were in network. When I had first moved to the US, I had started on an HMO plan...and it was bad. Like the time I went out of my way to go to what was supposed to be a Quest collection site for labwork, instead of letting my doctor do the labwork on site. And, end up getting fully charged for using an out of network lab, because the site had cancelled its contract with Quest the week before (but I had called Quest the morning of the test...so they shouldn't have misled me)....I complained, they apologized....but I never got the refund they said they would do.

Using Quest was only part of the HMO plan, so switching to PPO was good. Though later things changes to where if the practice where your primary has their own lab, the lab is automatically considered as in-network....so there was further savings, but I stayed with PPO because. Later they brought Quest in for PPO with some providers....I just picked the PPO provider that didn't use Quest.

Anyways....in my current job...Quest had jumped into the plans....though its optional. And, the Quest collection site isn't anywhere that can be reached on foot (and I'm kind of down to just the one foot now)...and the doctors in my area won't participate with Quest. At first it was part of the HMO, later it extended to Plan A & Plan B (since all 3 plans are PPO now). But, its still optional, and the labs that my doctors do use are in-network.

When I started, I went with BCBS....because I hadn't established relationships with local doctors, but BCBS had the larger network...both in state and out of state, and with relatives scattered around the country/world....access to a large out of state network was important. Plus now that I also attend conferences, conventions and such...it is hopefully less of a worry.

But, when they switched from HMO, PPO, QHDHP to the Plan A, B, C naming....I switched to Plan A. Which was at first explained as the HMO plan with PPO features. But, now they just say all 3 are PPO plans....just different cost structures.

I never really considered the QHDHP option...because I never really understood FSA/HSAs in the beginning....wasn't until 2009 that I started using an FSA. And, the steep deductible scared me (still is scary). Though one thing that intrigued me at this job, was that the prescription plan on the QHDHP/Plan C option was different from the HMO/PPO/Plan A&B one. The A&B plan was co-insurance, no deductible...the typical 3 tiers with some extras classes. When I started, it wasn't an issue...since most of the stuff I took was either generic or preferred brand (well, when I first moved to Kansas I was on Prevacid, which wasn't a preferred brand....but primary switched me back down to Prilosec which is generic. Though can't help wonder if my health taking its turn for the worse didn't start when that change was made...and now that Prevacid is available as generic....:hmm:) Anyways...Plan C's prescription plan was co-pays after deductible, which was the kind of prescription coverage I bad before I came here. Not always a good thing though...since $10 co-pay for generic.. where as I have a couple of generics where the 20% co-insurance is less...some generics I've had fill come out to $0.92, $2.02, $3.53, $1.58, $1.39....on the other hand...the co-insurance on branded meds were costing me much more than co-pay....and the worse ones were yet to come.

So, in open enrollment 2008 (for 2009), I decided that it was time to see what all this FSA business was about. I went with a minimal contribution....$300 for the year. Well, I didn't know at the time, that combined with the results of my first 'free' Healthquest screening from work and my annual physical (Well Man Exam) that I'm not supposed to be sleepy all the time, have experience that surge in weight gain during the summer, fall asleep easily during the day, including at least one uncontrolled nap each day.... I just knew that in 2009, co-insurance was change from 10% to 20%, and co-pays were going up.... But, I had my first sleep study in December 2008. I got initial setup that month...so 10% co-insurance versus 20% was a good thing, plus deductible was less, and already met, in 2008 than in 2009.

But, because of the OSA dx, I quickly met my deductible (which had gone from $50 to $150) and spent my entire FSA amount in the first week of 2009.

So, in open enrollment 2009, I decided that I should put more into FSA....but I didn't expect that I would have the same kind of major expenses that I had, so I increased my amount to only $1200. This was even though I had an accident in august of 2009, and it had cost me quite a bit. But, it was the accident that kept on giving....When I got my teeth cleaned in Jan 2010, it was discovered that I had cracked some teeth in the accident....so the $1200 was gone in a couple of months.

Meanwhile...in 2010, I was introduced to Provigil and Lunesta. The co-insurance on Provigil was about $380 a month, and Lunesta was about $112 a month. Plus then I had an accident in November of 2010, and another sleep study in December. What I discovered though was what happens when I hit my co-insurance maximum for 2010. I still have to pay co-pays...but after than everything is covered in full. While reading over the plans on co-insurance maximum, I saw that the prescription plan had a separate co-insurance max of $2850. I wasn't going to reach it in 2010, with the Provigil costs....and Lunesta didn't count towards it (even though they said if you had tried two other prescriptions before it, they would...which I had....they did require my pharmacist to call in to get permission to fill it, even though they would already know that I had been on prescribed 3 different ones before it. Though I guess 2 of them were off-label? Though the PDL only lists one drug for the class, which I had been on, and only generics...they have no preferred brand.) Provigil is also alone, as the preferred brand....though it is quite different than the other types of stimulants (Ritalin, Adderall, Concerta, Dex, etc.)

So, in open enrollment 2010, I considered switching to Plan C. They still keep telling everybody that Plan C/QHDHP is only for super healthy people. But, because of the co-pay structure of the prescription plan (after deductible)...I wondered if it might not be the better way to go.... It would take 1.5 months worth of Provigil to meet the deductible..and then I would only have to pay a $30 co-pay. Maybe sooner, depending on what else happened at the start of the year. I didn't know I was going to break my foot in November 2010. What I did find out was that one of my meds was capped at $20 a month (Singulair), where as it would be $30 co-pay with Plan C. The Plan C prescription plan didn't have the specialty tiers for things like diabetes, asthma, anti-cancer.... and it wasn't like I was on Xyrem or something super expensive. Though I had looked, and Xyrem is on the list of specialty meds, so its a $75 co-pay.

But, I had missed the open enrollment presentation (because I had gone to the NN Conference) and I didn't have a lot of answers on why they only consider Plan C for super healthy types....and not somebody like me.

The other problem is that with an FSA I can spend all the money I plan to put into it before the money is actually in it. While with an HSA, the money needs to be there first. They did say the first year is the hardest.... So, running out of time, I quickly locked in my discount status, staying with Plan A & BCBS and other stuff...and went with putting the out-of-pocket maximum of Plan C into my FSA (which is less than the current maximum that I could put into an FSA.) I had skimmed the networks of the other providers...to see if my current doctors were in, and whether they offered any other choices that BCBS didn't....

Well, I spent all my FSA for this year in about 4.5 months...and only because I switched to only submitting the bigger claims after I got my tax refund.... Though this year the the deductible did feel more painful. It had gone from $150 to $300...but I also didn't have the big expenses early in the year...so it was a bunch of little things where I had to pay the full discounted amount... Not sure where I stand on reaching co-insurance max this year for health ($1400)....

Had I still been on Provigil...I would've reached co-insurance max on the prescription plan around July...but as I had been warned at the NN Conference, I would build tolerance to it...and it stopped working in spring time.....where I was then switched to Ritalin.... And, I quickly built tolerance to that....so at the end of August I was switched to Nuvigil....which seems to be working better, and apparently its the other isomer that is in Provigil that we build tolerance to. I briefly tried Provigil again between refills, and it did little for me.

Problem with Nuvigil though is that its the non-preferred brand...so it doesn't count towards my co-insurance max....though I'm about $1000 away, so I probably won't hit it this year....even if I could've gotten the override (having tried Provigil and Ritalin before, should've met the tried two other drugs from the PDL first....also the co-pay coupon from Cephelon apparently doesn't work. Just as the co-pay coupon for Lunesta didn't work. They both say they won't work with plans that are state/federal government funded....so no discount for us poor state employees).

The other change this year is the prescription plan for Plan C has changed...its more like the Plan A&B one, except adjusted to fit the QHDHP. So instead of co-pays after deductible and continuing after out of pocket max is reached. It is just co-insurance after deductible and then 100% when out of pocket max is reached. And, tier 3 drugs count towards the out of pocket max (as do drugs on the anti-cancer tier).... Also with Plan C, there's no co-pays to see doctors....so once out of pocket max it reached....they're covered 100% in full. Didn't seem a huge deal before 2010...because PCP and sleep doctor were in the same medical home, so $25 co-pay for either....the only specialist where I had to pay $45 co-pays were related to physical therapy...and I didn't do that this year (though wonder if maybe it would help my walking issues since broken foot incident....maybe next year if things continue to worsen...)

Given how quickly my FSA went this year, and my current projected expenses (and the changes this year)....it shouldn't be that hard to reach the $1500 deductible or the $3000 out of pocket max in 2012...so it'll be interesting to see what it is like to have things covered 100% in full after that point. Especially since the current co-insurance on Nuvigil + Lunesta x 12 is more than the out of pocket max. I had considered asking about Nuvigil sooner, because paying 60% of it (non-preferred brand)...instead of 35% for preferred brand)....is about half the 35% I pay for Provigil. But, when the Provigil stopped working, doctor wanted to try Ritalin instead first....which did work in the beginning....but it didn't seem to matter to insurance on when I did get to be on Nuvigil. I decided that I would more strongly consider the switch to Plan C.

The fact that BCBS offered it was certainly a big factor, since I had concerns over network last year. And, during an open enrollment presentation..somebody asked why Plan C didn't work even if they hit the out of pocket max in the year (and all the money they put into the HSA)...

for an individual/in-network
Plan A has $300 deductible + $1400 co-insurance max & Rx has $2850 co-insurance max (where tier 3 doesn't count towards it)
Plan B has $150 deductible + $3000 co-insurance max & Rx has $2850 co-insurance max (where tier 3 doesn't count towards it)
Plan C has $1500 deductible -> $3000 out of pocket max & Rx works with the same deductible/out of pocket max (and tier 3 counts).

So sounds like if you know you're going to be out of pocket more than $3000 in a year...plan C is the way to go.

Plus with Plan A & B, the co-pays continue after the co-insurance max is hit. Plan A is $25 (Primary/Urgent Care), $45 (Specialist) and $100 (ER). Plan B is $20 (Primary), $25 (Urgent Care), $40 (Specialist) and $100 (ER)....there's an advantage for families, where co-pay for children is $10 (Primary) or $25 (Specialist)....

In addition to no co-pays with Plan C (versus Plan A)....there are two other differences, the Manipulation Therapy (IE: Chiropractor) is reduced to max of 26 per year (from 30). And the Durable Medical Equipment maximum is lowered to $1000/year (from $5000/year).

Since I just got a new CPAP machine this year, I don't anticipate my DME expenses to be more than $1000...in fact the new machine plus supplies this year shouldn't break the $1000 mark. But, who knows what the future holds.

So, since United Health Care is a new provider this year....I started to think that I should check out its network as to whether to stay with BCBS or not. In the first open enrollment presentation, I didn't stay for the HSA presentation. Because I was at first thinking that I would stay with Plan A, and this time put the $5000 max into FSA....before healthcare reform lowers the max to $2500. But, in the time between the morning presentation and the afternoon one, I started the research on Plan C/HDHP/HSAs, etc. And, decided I wanted to hear the HSA presentation.

Fortunately, they did that one first in the afternoon session.

So, I instead looked at the HSAs associated with the 3 providers....and decided that BCBS would be who I would go with.

The BCBS HSA has a maintenance fee that falls between the other two (close to the low end, where the high end one is significantly higher...and the one for UHC). The interest rate structures differed, but all were insignificant for low balances. The other two, offer maintenance fee elimination with a minimum balance. The lower one waives off at $3000, the higher one waives off at $5000....there's differences in investment options and additional fees. BCBS HSA has a lot less in the additional fees area. And, what investment options it offered seemed ok.

But, given that I'm expecting to hit out-of-pocket max (which is the contribution max for the HSA)....how much the HSA will cost for little or no balance weighed in. Though I will probably build some of my HSA over time...since initial expenses will be before the HSA is sufficiently funded, and I may or may not chose to use HSA funds to meet all my later out of pocket expenses.

On the additional side, I opted to go with $600 for a limited use FSA (Dental and Vision....I have one dental related prescription, and I anticipate the buying a new pair of glasses every year to be a trend that continues indefinitely.) I kept my Vision insurance.

Now to see how 2012 goes....